Home / 510(k) Clearances / K894715

510(k) K894715

CREATINE KINASE FOR MANUAL/AUTOMATED APPLICATIONS by Catachem, Inc. — Product Code CGS

K894715 is an FDA 510(k) premarket notification submitted by Catachem, Inc. for the device "CREATINE KINASE FOR MANUAL/AUTOMATED APPLICATIONS". The FDA issued a decision of Substantially Equivalent on November 8, 1989. The device falls under product code CGS (Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes), a Class II device regulated under 21 CFR 862.1215. Catachem, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 8, 1989
Date Received
July 25, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes
Device Class
Class II
Regulation Number
862.1215
Review Panel
CH
Submission Type

Other clearances by Catachem, Inc.

  • K062503 — CATACHEM, INC., BILE ACIDS REAGENTS AND/OR BILE ACIDS TEST KIT (January 19, 2007)
  • K945408 — 340-CHLORIDE FOR DISCRETE RANDOM ACCESS ANALYZER (February 22, 1995)
  • K932871 — UIBC FOR DISCREET RANDOM ACCESS ANALYZER (September 8, 1993)
  • K903341 — MAGNESIUM (August 22, 1990)
  • K902326 — AMYLASE FOR MANUAL/AUTOMATED APPLICATIONS (July 31, 1990)
  • K902877 — TOTAL IRON FOR MANUAL/AUTOMATED (July 27, 1990)
  • K895748 — BICARBONATE FOR MANUAL/AUTOMATED APPLICATIONS (December 21, 1989)
  • K895821 — URIC ACID FOR MANUAL/AUTOMATED APPLICATIONS (December 5, 1989)
  • K894476 — CALCIUM (ARSENAZO III) FOR MANUAL/AUTO APPLICATION (October 12, 1989)
  • K894389 — CREATININE FOR MANUAL OR AUTOMATED APPLICATIONS (October 12, 1989)

Other clearances for product code CGS

  • K191296 — Pointe Scientific Creatinine Kinase (CK) Reagent Set (August 11, 2020)
  • K182702 — SEKURE Creatine Kinase Assay (April 17, 2019)
  • K160724 — ADVIA Chemistry Creatine Kinase (CK_L) Assay, ADVIA Chemistry Enzyme 3 Calibrato (September 7, 2016)
  • K123977 — RANDOX LIQUID CK-MB, RANDOX CK-MB CALIBRATOR (November 21, 2013)
  • K112416 — CPK REAGENT (November 9, 2011)
  • K083465 — DIMENSION VISTA CREATINE KINASE FLEX REAGENT CARTRIDGE AND DIMENSION VISTA CREAT (February 27, 2009)
  • K081731 — DIMENSION CKI FLEX REAGENT CARTRIDGE, DIMENSION MBI FLEX REAGENT CARTRIDGE, AND (August 29, 2008)
  • K072548 — CREATINE KINASE LIQUID REAGENT, MODEL C519-440 (April 18, 2008)
  • K062737 — CARDIAC MARKERS ON ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER (June 12, 2007)
  • K051648 — SPOTCHEM II INOGANIC PHOSPHORUS, CPK AND URIC ACID TESTS (January 31, 2006)

FDA data resources