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510(k) K820418

K.D. COLORIMETRIC BLOOD UREA N2 TEST by King Diagnostics, Inc. — Product Code JGZ

K820418 is an FDA 510(k) premarket notification submitted by King Diagnostics, Inc. for the device "K.D. COLORIMETRIC BLOOD UREA N2 TEST". The FDA issued a decision of Substantially Equivalent on March 11, 1982. The device falls under product code JGZ (O-Phthalaldehyde, Urea Nitrogen), a Class II device regulated under 21 CFR 862.1770. King Diagnostics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 11, 1982
Date Received
February 16, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
O-Phthalaldehyde, Urea Nitrogen
Device Class
Class II
Regulation Number
862.1770
Review Panel
CH
Submission Type

Other clearances by King Diagnostics, Inc.

  • K933329 — KING DIAGNOSTICS IRON AND TOTAL IRON BINDING CAPACITY REAGENT (October 22, 1993)
  • K931834 — KING SODIUM/POTASSIUM STANDARD MODIFIED (August 25, 1993)
  • K931773 — HDL PRECIPITATING REAGENT (DEXTRAN SULFATE) (August 16, 1993)
  • K931326 — KING DIAGNOSTICS CK REAGENT (June 15, 1993)
  • K923129 — KING DIAGNOSTICS GLUCOSE (HK) REAGENT (November 2, 1992)
  • K922969 — KING DIAGNOSTICS UREA NITROGEN REAGENT (October 13, 1992)
  • K922921 — KING DIAGNOSTICS CHLORIDE REAGENT (October 5, 1992)
  • K923927 — KING DIAGNOSTICS MAGNESIUM REAGENT (September 30, 1992)
  • K923091 — KING DIAGNOSTICS GAMMA GT REAGENT (September 9, 1992)
  • K923128 — KING DIAGNOSTICS CHOLESTEROL REAGENT (September 9, 1992)

Other clearances for product code JGZ

  • K904049 — ROCHE COBAS READY RENAL PROFILE REAGENT STRIP (October 12, 1990)
  • K896236 — COBAS READY BUN REAGENT (February 27, 1990)
  • K883327 — CLINISTAT BUN (BLOOD UREA NITROGEN) REAGENT TEST (January 23, 1989)
  • K863901 — IQ UREA NITROGEN (November 24, 1986)
  • K842772 — PHARMACIA B2-MICRO RIA (November 1, 1984)
  • K840213 — BLOOD UREA NITROGEN REAGENT SYS (March 19, 1984)
  • K810087 — UREA NITROGEN, KINETIC (February 26, 1981)
  • K801269 — SERALYZER BLOOD UREA NITROGEN(BUN) (July 8, 1980)
  • K792362 — BLOOD UREA NITROGEN REAGENT (December 6, 1979)
  • K770504 — REAGENT SYSTEM (June 27, 1977)

FDA data resources