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510(k) K811694

CENTRIFICHEM ALT/AGPT OPTIMIZED REAGENT by Baker Instructions Corp. — Product Code CKA

K811694 is an FDA 510(k) premarket notification submitted by Baker Instructions Corp. for the device "CENTRIFICHEM ALT/AGPT OPTIMIZED REAGENT". The FDA issued a decision of Substantially Equivalent on July 1, 1981. The device falls under product code CKA (Nadh Oxidation/Nad Reduction, Alt/Sgpt), a Class I device regulated under 21 CFR 862.1030. Baker Instructions Corp. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 1, 1981
Date Received
June 15, 1981
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 Baker Instructions Corp.

  • K882612 — SYSTEM 9000 DIFF MODEL AUTOMATED CELL COUNTER (September 7, 1988)
  • K873596 — BAKER TDM THEOPHYLLINE ASSAY (October 20, 1987)
  • K870603 — SYSTEM 9000 AUTOMATED CELL COUNTER (March 31, 1987)
  • K854173 — UCD URINE SPECIMEN COLLECTOR (November 4, 1985)
  • K850386 — SYSTEM 8000 CELL COUNTER (May 2, 1985)
  • K833116 — SPIRIT CHEMISTRY SYSTEM (November 7, 1983)
  • K832716 — ENCORE CHEMISTRY ANALYZER (October 4, 1983)
  • K830641 — ENCORE CHEMISTRY ANALYZER (April 5, 1983)
  • K821956 — HAEM-C PLUS BLOOD REFERENCE CONTROLS (July 30, 1982)

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