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510(k) K895984

WAKO(TM) AUTOKIT GAMMA-GT by Wako Chemicals USA, Inc. — Product Code JPZ

K895984 is an FDA 510(k) premarket notification submitted by Wako Chemicals USA, Inc. for the device "WAKO(TM) AUTOKIT GAMMA-GT". The FDA issued a decision of Substantially Equivalent on Nov 8, 1989. The device falls under product code JPZ (Colorimetric Method, Gamma-Glutamyl Transpeptidase), a Class I device regulated under 21 CFR 862.1360. Wako Chemicals USA, Inc. has 123 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Nov 8, 1989
Date Received
Oct 13, 1989
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
510(k) Exempt

Other clearances by Wako Chemicals USA, Inc.

  • K100464 — UTASWAKO I30 (INCLUDES ACCESSORIES), UTASWAKO AFP-L3, CALIBRATOR SET, CONTROL L… (Feb 23, 2011)
  • K080125 — APOLOWAKO T-CHO, HDL-C, TG AND ANALYZER, MODELS 993-23501, 999-23601, 995-23701… (Jul 18, 2008)
  • K080123 — APOLOWAKO HBA1C, GLUCOSE AND ANALYZER, MODELS 993-24601, 991-24401 AND 993-25201 (Jul 17, 2008)
  • K061775 — WAKO L-TYPE CREATININE-M TEST, AND WAKO CREATININE CALIBRATOR (Feb 23, 2007)
  • K062368 — WAKO LBA DCP TEST SYSTEM, MODEL 993-05301; DCP CONTROL SET, MODEL 995-0551; DCP… (Jan 31, 2007)
  • K053131 — WAKO TOTAL BILIRUBIN V, MODELS 410-22701, 998-23291, 416-22801, 990-23191 (Dec 30, 2005)
  • K053132 — WAKO DIRECT BILIRUBIN V, MODELS 996-23591, 412-22901, 992-23691, 998-23791 (Dec 30, 2005)
  • DEN050002 — LBA AFP-L3, AFP-L3 CALIBRATOR SET, AFP-L3 CONTROL SET AND LIBASYS (May 19, 2005)
  • K042551 — MULTI-CHEM CALIBRATOR A (Nov 16, 2004)
  • K042549 — MULTI CHEM CAL B (Nov 8, 2004)

Other clearances for product code JPZ

  • K020486 — CARESIDE GGT (Jul 1, 2002)
  • K961919 — DMA GAMMA GLUTAMYLTRANSFERASE (GGT) PROCEDURE (Jul 1, 1996)
  • K923509 — GAMMA-GT (Dec 3, 1992)
  • K923091 — KING DIAGNOSTICS GAMMA GT REAGENT (Sep 9, 1992)
  • K905618 — GGT REAGENT (Feb 26, 1991)
  • K903304 — ROCHE COBAS READY GGT REAGENT (Oct 12, 1990)
  • K901090 — ELITECH GAMMA GT TEST KIT (Mar 29, 1990)
  • K881239 — GAMMA GLUTAMYL TRANSFERASE REAGENT SET (May 31, 1988)
  • K874903 — MULTICHEM(R) Y -GLUTAMYLTRANSFERASE (Y -GT) (Feb 11, 1988)
  • K871979 — GAMMA GLUTAMYLTRANSFERASE REAGENT (Jun 11, 1987)

FDA data resources

Source: FDA 510(k) database entry for K895984. Report a data issue: hello@regdatalab.com.