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510(k) K870879

ALANINE TRANSAMINASE (ALT) TEST KIT by Genetic Systems Corp. — Product Code CKA

K870879 is an FDA 510(k) premarket notification submitted by Genetic Systems Corp. for the device "ALANINE TRANSAMINASE (ALT) TEST KIT". The FDA issued a decision of Substantially Equivalent on March 19, 1987. The device falls under product code CKA (Nadh Oxidation/Nad Reduction, Alt/Sgpt), a Class I device regulated under 21 CFR 862.1030. Genetic Systems Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 19, 1987
Date Received
March 4, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Nadh Oxidation/Nad Reduction, Alt/Sgpt
Device Class
Class I
Regulation Number
862.1030
Review Panel
CH
Submission Type

Other clearances by Genetic Systems Corp.

  • K891767 — GENETIC SYSTEMS MICROPLATE READER (July 25, 1989)
  • K891765 — GENETIC SYSTEMS PIPETTOR/DILUTOR (May 1, 1989)
  • K891768 — GENETIC SYSTEMS MICROPLATE WASHER (May 1, 1989)
  • K891766 — GENETIC SYSTEMS MICROPLATE STRIP WASHER (May 1, 1989)
  • K890768 — PNEUMOCYSTIS CARINII IMMUNOFLUORESCENCE TEST KIT (March 21, 1989)
  • K873564 — GENETIC SYSTEMS RSV REAGENT CONTROL SLIDES (November 20, 1987)
  • K873542 — MICROPLATE AUTO-WASHER (MOTORIZED STAGE) (September 23, 1987)
  • K870176 — GENETIC SYSTEMS RSV IMMUNOFLUORESCENCE TEST KIT (July 16, 1987)
  • K863566 — GSC 1000 (October 16, 1986)
  • K852237 — LEGIONELLA IMMUNOFLUORESCENT ANTIBODY TEST KIT (August 22, 1985)

Other clearances for product code CKA

  • K120945 — HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE ALT, HITACHI CLINICAL ANALYZE (June 7, 2013)
  • K113382 — ACE ALT REAGENT (July 19, 2012)
  • K061020 — DIMENSION VISTA ALBUMIN, ALKALINE PHOSPHATASE, ASPARTATE AMINO TRANSFERASE, CARB (May 10, 2006)
  • K020487 — CARESIDE ALT (June 4, 2002)
  • K980028 — ALT (GPT) LIQUID STABLE 2 VIAL - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY (February 2, 1998)
  • K973869 — TRACE REAGENT LINE FOR THE COBAS MIRA (January 7, 1998)
  • K974003 — ALANINE AMINOTRANSFERASE-SL ASSAY CATALOGUE NUMBER 318-10, 318-30 (December 5, 1997)
  • K971323 — ALT OR SGPT (April 21, 1997)
  • K965134 — ALT/SGPT (February 18, 1997)
  • K961123 — ALT INCORPORATING DST (April 25, 1996)

FDA data resources