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510(k) K850788

GLUTAMYLTRANSFERASE ASSAY KIT by Diagnostic Chemicals, Ltd. (Usa) — Product Code JPZ

K850788 is an FDA 510(k) premarket notification submitted by Diagnostic Chemicals, Ltd. (Usa) for the device "GLUTAMYLTRANSFERASE ASSAY KIT". The FDA issued a decision of Substantially Equivalent on March 19, 1985. The device falls under product code JPZ (Colorimetric Method, Gamma-Glutamyl Transpeptidase), a Class I device regulated under 21 CFR 862.1360. Diagnostic Chemicals, Ltd. (Usa) has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 19, 1985
Date Received
February 26, 1985
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 Diagnostic Chemicals, Ltd. (Usa)

  • K022538 — IMMUNODIP URINARY ALBUMIN SCREEN ASSAY, CATALOGUE NUMBER 790-25 (August 23, 2002)
  • K974874 — BILIRUBIN-SL (TOTAL) ASSAY (February 12, 1998)
  • K932556 — AMMONIA ASSAY CAT. NO. 200-02 (August 2, 1994)
  • K932766 — HDL-CHOLESTRAL(DEXTRAN SULFATE/MAGNESIUM) (December 10, 1993)
  • K932555 — DC-LINEATE CAT. NO. SE-091 (August 19, 1993)
  • K925877 — DC-UIBC-CAL (March 18, 1993)
  • K912825 — MAGNESIUM ASSAY KIT, CAT.# 100-12 (July 26, 1991)
  • K895964 — DCL SYPHILIS-M CATALOG NO. 600-80 (January 8, 1991)
  • K895965 — DCL - SYPHILIS-G ASSAY CATALOG NO. 600-70 (December 26, 1990)
  • K904660 — ENZYMATIC BILIRUBIN (TOTAL), CATALOGUE NO. 202-14 (November 20, 1990)

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