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510(k) K945800

Y-GLUTAMYLTRANSFERASE ASSAY, CATALOGUE NUMBER 308-05 by Diagnostic Chemicals , Ltd. — Product Code JQB

K945800 is an FDA 510(k) premarket notification submitted by Diagnostic Chemicals , Ltd. for the device "Y-GLUTAMYLTRANSFERASE ASSAY, CATALOGUE NUMBER 308-05". The FDA issued a decision of Substantially Equivalent on June 9, 1995. The device falls under product code JQB (Kinetic Method, Gamma-Glutamyl Transpeptidase), a Class I device regulated under 21 CFR 862.1360. Diagnostic Chemicals , Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 9, 1995
Date Received
November 28, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by Diagnostic Chemicals , Ltd.

  • K070383 — ENZYMATIC CREATININE ASSAY (265 SERIES) (June 22, 2007)
  • K063208 — MAGNESIUM ASSAY (XB), MODELS 125-12, 125-50 AND 125-S7 (January 19, 2007)
  • K060139 — CRP-ADVANCE ASSAY, MODELS 250-20, 250-25 (April 28, 2006)
  • K060140 — CRP-ADVANCE MULTI CALIBRATOR SET, MODEL SE-250 (April 24, 2006)
  • K051757 — CALCIUM ADVANCE ASSAY, MODEL 145-20, 145-25, 145-20-91 (November 10, 2005)
  • K051191 — DCL MICROALBUMIN ASSAY, MODEL 252-20 (July 5, 2005)
  • K042330 — ACETAMINOPHEN-SL ASSAY (January 7, 2005)
  • K042362 — MODIFICATION TO CARBON DIOXIDE-L3K ASSAY, CAT. NOS. 299-30, 299-17, 299-50, 299- (December 27, 2004)
  • K042329 — SALICYLATE-SL ASSAY (December 27, 2004)
  • K041928 — HDL-ADVANCE ASSAY, CAT. NO. 278-20, 278-50A, 278-50B (November 23, 2004)

Other clearances for product code JQB

  • K974000 — Y-GLUTAMYLTRANSFERASE-SL ASSAY , CATALOGE NUMBER 324-10, 324-30 (November 4, 1997)
  • K973157 — LIQUID GGT (GAMMA GLUTAMYL TRANSFERASE) REAGENT SET (October 10, 1997)
  • K971466 — SYNCHRON CX SYSTEMS GAMMA-GLUTAMYL TRANSFERASE REAGENT (GGT) (May 6, 1997)
  • K964457 — ROCHE COBAS IBTEGRA REAGENT CASSETTES (January 13, 1997)
  • K964916 — GAMMA-GLUTAMYL TRANSPEPTIDASE (January 10, 1997)
  • K955770 — GAMMA GLUTAMYL TRANSFERASE TEST SYSTEM (September 9, 1996)
  • K946192 — HICHEM Y-GT REAGENT KIT (May 2, 1995)
  • K942962 — GGT QVET (December 7, 1994)
  • K935984 — GLUTAMYL-TRANSFERASE, PROCEDURE NO. 419 (July 20, 1994)
  • K941315 — STANBIO Y-GT (LIQUICOLOR) TEST SET (July 14, 1994)

FDA data resources