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510(k) K760346

ASSAY FOR GAMMA GLUTAMYLTRANSFERASE by Princeton Biomedix — Product Code JPZ

K760346 is an FDA 510(k) premarket notification submitted by Princeton Biomedix for the device "ASSAY FOR GAMMA GLUTAMYLTRANSFERASE". The FDA issued a decision of Substantially Equivalent on October 27, 1976. The device falls under product code JPZ (Colorimetric Method, Gamma-Glutamyl Transpeptidase), a Class I device regulated under 21 CFR 862.1360. Princeton Biomedix has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 27, 1976
Date Received
August 2, 1976
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Colorimetric Method, Gamma-Glutamyl Transpeptidase
Device Class
Class I
Regulation Number
862.1360
Review Panel
CH
Submission Type

Other clearances by Princeton Biomedix

  • K942052 — LIFESIGN MI MYOGLOBIN (February 7, 1995)
  • K925355 — BIOSIGN(TM_ RUBELLA - RUBELLA ANTIBODY TEST (July 12, 1994)
  • K930185 — OVUSIGN LH/CONCEPTION PLUS/OVUDATE LH ONE-STEP (March 4, 1993)
  • K925183 — BIOSIGN(TM) MONO-INFECT MONO HETERO ANTIBODY TEST (February 23, 1993)
  • K926308 — LIFESIGN HCG - ONE STEP HOME PREGNANCY TEST (January 26, 1993)
  • K901011 — BIOSIGN HCG-ONE STEP PREGNANCY TEST (May 4, 1990)
  • K894750 — BIOSTIX I. HCG - ONE STEP PREGNANCY TEST (October 18, 1989)
  • K894705 — BIOSPOT HCG-RAPID PREGNANCY TEST (October 18, 1989)
  • K892654 — BIOSTIX (TM)HCG--SIMPLE PREGNANCY TEST (June 19, 1989)
  • K761315 — ALKALINE PHOSPHATASE (ALP)/PNPP (February 24, 1977)

Other clearances for product code JPZ

  • K020486 — CARESIDE GGT (July 1, 2002)
  • K961919 — DMA GAMMA GLUTAMYLTRANSFERASE (GGT) PROCEDURE (July 1, 1996)
  • K923509 — GAMMA-GT (December 3, 1992)
  • K923091 — KING DIAGNOSTICS GAMMA GT REAGENT (September 9, 1992)
  • K905618 — GGT REAGENT (February 26, 1991)
  • K903304 — ROCHE COBAS READY GGT REAGENT (October 12, 1990)
  • K901090 — ELITECH GAMMA GT TEST KIT (March 29, 1990)
  • K895984 — WAKO(TM) AUTOKIT GAMMA-GT (November 8, 1989)
  • K881239 — GAMMA GLUTAMYL TRANSFERASE REAGENT SET (May 31, 1988)
  • K874903 — MULTICHEM(R) Y -GLUTAMYLTRANSFERASE (Y -GT) (February 11, 1988)

FDA data resources