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510(k) K810853

CK-TOTAL/CK-B (NAC) BIOLUMIN. ASSAY KIT by The Upjohn Co. — Product Code CGS

K810853 is an FDA 510(k) premarket notification submitted by The Upjohn Co. for the device "CK-TOTAL/CK-B (NAC) BIOLUMIN. ASSAY KIT". The FDA issued a decision of Substantially Equivalent on May 29, 1981. The device falls under product code CGS (Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes), a Class II device regulated under 21 CFR 862.1215. The Upjohn Co. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 29, 1981
Date Received
March 30, 1981
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 The Upjohn Co.

  • K902004 — TROBICIN SUSCEPTIBILITY POWDER (May 15, 1990)
  • K900455 — ZEFAZONE SUSCEPTIBILITY POWDER (February 9, 1990)
  • K782009 — RIA KIT, PROGESTERONE (March 2, 1979)
  • K780792 — TESTOSTERONE RADIOIMMUNOASSAY KIT 125I (June 13, 1978)
  • K760920 — CAT-A-KIT (November 9, 1976)

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