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510(k) K961196

EKTACHEM CLINICAL CHEMISTRY UREA NITROGEN/UREA (BUN/UREA) by Johnson & Johnson Clinical Diagnostics, Inc. — Product Code CDN

K961196 is an FDA 510(k) premarket notification submitted by Johnson & Johnson Clinical Diagnostics, Inc. for the device "EKTACHEM CLINICAL CHEMISTRY UREA NITROGEN/UREA (BUN/UREA)". The FDA issued a decision of Substantially Equivalent on May 15, 1996. The device falls under product code CDN (Urease, Photometric, Urea Nitrogen), a Class II device regulated under 21 CFR 862.1770. Johnson & Johnson Clinical Diagnostics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 15, 1996
Date Received
March 27, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Urease, Photometric, Urea Nitrogen
Device Class
Class II
Regulation Number
862.1770
Review Panel
CH
Submission Type

Other clearances by Johnson & Johnson Clinical Diagnostics, Inc.

  • K980283 — VITROS CHEMISTRY PRODUCTS CRBM SLIDES (February 25, 1998)
  • K974644 — VITROS IMMUNODIAGNOSTIC PRODUCTS RANGE VERIFIERS (January 13, 1998)
  • K973517 — VITROS IMMUNODIAGNOSTIC PRODUCTS RANGE VERIFIERS (September 25, 1997)
  • K973030 — VITROS IMMUNODIAGNOSTICS PRODUCTS/CK-MB REAGENT PACK(GEM.1300)/CK-MB CALIBRATORS (September 4, 1997)
  • K972133 — VITROS IMMUNODIAGNOSTICS PRODUCTS PROGESTERONE REAGENT PACK (GEM.1070), PROGESTE (June 24, 1997)
  • K970894 — VITROS IMMUNODIAGNOSTICS PRODUCTS TOTAL B-HCG REAGENT PACK (GEM.1075), TOTAL B-H (April 14, 1997)
  • K965142 — VITROS IMMUNODIAGNOSTICS PRODUCTS FREE T4 REAGENT PACK (GEM.1015) FREE T4 CALIBR (March 18, 1997)
  • K970643 — VITROS IMMUNODIAGNOSTICS PRODUCTS ESTRADIOL REAGENT PACK(GEM. 1050)/ESTRADIOL CA (March 18, 1997)
  • K970281 — VITROS IMMUNODIAGNOSTIC PRODUCTS PROLACTIN REAGENT PACK/CALIBRATORS (February 25, 1997)
  • K964982 — VITROS IMMUNODIAGNOSTICS PRODUCTS LH REAGENT PACK (GEM.1055) AND LH CALIBRATORS (February 20, 1997)

Other clearances for product code CDN

  • K190326 — VITROS XT Chemistry Products UREA-CREA Slides (March 14, 2019)
  • K132462 — S TEST REAGENT CARTRIDGE BUN AND S TEST REAGENT CARTRIDGE CRE (October 28, 2013)
  • K123322 — ACE BUN/UREA REAGENT, ACE CREATININE REAGENT, ACE URIC ACID REAGENT, ACE CK REAG (May 21, 2013)
  • K113389 — ACE CK REAGENT,ACE BUN/UREA REAGENT,ACE URIC ACID REAGENT,ACE CREATININE REAGENT (August 10, 2012)
  • K103615 — ACE UREA NITROGEN REAGENT, CALCIUM-ARSEAZO REAGENT, CREATININE REAGENT, INORGANI (September 8, 2011)
  • K001885 — VITROS CHEMISTRY PRODUCTS BUN/UREA SLIDES AND VITROS CHEMISTRY PRODUCTS CALIBRAT (July 20, 2000)
  • K972012 — CHOLESTECH BUN/CREATININE TEST SYSTEM (July 24, 1997)
  • K943042 — BUN QVET (December 29, 1994)
  • K922969 — KING DIAGNOSTICS UREA NITROGEN REAGENT (October 13, 1992)
  • K914903 — QUICKSTART UREA NITROGEN (December 31, 1991)

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