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510(k) K842104

TOYO JOZO G-GTP TEST by Advocacy International, Ltd. — Product Code JPZ

K842104 is an FDA 510(k) premarket notification submitted by Advocacy International, Ltd. for the device "TOYO JOZO G-GTP TEST". The FDA issued a decision of Substantially Equivalent on August 10, 1984. The device falls under product code JPZ (Colorimetric Method, Gamma-Glutamyl Transpeptidase), a Class I device regulated under 21 CFR 862.1360. Advocacy International, Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 10, 1984
Date Received
May 25, 1984
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 Advocacy International, Ltd.

  • K874027 — LIPASE UV [TOYO] (May 27, 1988)
  • K873792 — SEPACELL R-500 AND SEPACELL R-500A (January 19, 1988)
  • K855251 — MODIFICATION ASAHI NEW PAN-SERIES HEMOFILTERS (February 4, 1986)
  • K855212 — ASAHI AM SERIES DIALYZERS (January 21, 1986)
  • K854259 — SEPACELL R-500 & SEPACELL R-500A (January 8, 1986)
  • K842103 — TOYO JOZO URIC ACID TEST (August 12, 1984)
  • K830183 — ASAHI HOLLOW FIBER KIDNEYS NR SERIES (March 17, 1983)
  • K830231 — ASAHI HOLLOW FIBER KIDNEYS, AM-SERIES (March 17, 1983)
  • K823733 — EIKEN KIZAI ARTIFICIAL KIDNEY BLOOD CIR (January 14, 1983)
  • K813037 — FLOWGUARD CATHETERS & CANNALAE (December 14, 1981)

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