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510(k) K863889

UREA NITROGEN TEST by U. S. Diagnostics, Inc. — Product Code CDL

K863889 is an FDA 510(k) premarket notification submitted by U. S. Diagnostics, Inc. for the device "UREA NITROGEN TEST". The FDA issued a decision of Substantially Equivalent on November 24, 1986. The device falls under product code CDL (Berthelot Indophenol, Urea Nitrogen), a Class II device regulated under 21 CFR 862.1770. U. S. Diagnostics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 24, 1986
Date Received
October 6, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Berthelot Indophenol, Urea Nitrogen
Device Class
Class II
Regulation Number
862.1770
Review Panel
CH
Submission Type

Other clearances by U. S. Diagnostics, Inc.

  • K110435 — EASYGLUCO PLUS BLOOD GLUCOSE MONITORING SYSTEM (September 21, 2011)
  • K082201 — G5 INFINITY BLODO GLUCOSE MONITORING SYSTEM WITH MODEL IGM, 0024A (February 20, 2009)
  • K061431 — EASYGLUCO, MODEL IGM-0002 G2 (January 12, 2007)
  • K051651 — G4, MODEL IGM-0004 (April 14, 2006)
  • K870685 — COAGULATION CONTROL, LEVEL I (April 20, 1987)
  • K870596 — PROTHROMBIN TIME TEST (April 20, 1987)
  • K870687 — COAGULATION CONTROL, LEVEL III (April 20, 1987)
  • K870686 — COAGULATION CONTROL, LEVEL II (April 20, 1987)
  • K871283 — CYANMETHEMOGLOBIN STANDARD (April 15, 1987)
  • K870737 — U.S. DIAGNOSTICS LIQUID LD ISOENZYME CONTROL (April 13, 1987)

Other clearances for product code CDL

  • K896845 — RAICHEM(TM) UREA NITROGEN (COLOR) REAGENT (February 16, 1990)
  • K893128 — STANBIO ENZYMATIC UREA NITROGEN DETERMINAT #2010 (July 25, 1989)
  • K871651 — COLORIMETRIC BUN REAGENT KIT (May 12, 1987)
  • K864742 — UREA NITROGEN(BUN), COLORIMETRIC METHOD (January 13, 1987)
  • K863076 — UREAFAST (September 9, 1986)
  • K860154 — BUN (ENZYMATIC BERTHELOT) REAGENT SET (February 6, 1986)
  • K831414 — COLORIMETRIC BUN (June 16, 1983)
  • K822237 — UREA NITROGEN REAGENT SET (MOD. BERTHEL (August 16, 1982)
  • K810261 — EUROCHIMA UREA NITROGEN (February 10, 1981)
  • K801727 — DATA-ZYME UREA NITROGEN, COLORIMETRIC (September 9, 1980)

FDA data resources