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510(k) K950177

CK QVET by Prisma Systems — Product Code CGS

K950177 is an FDA 510(k) premarket notification submitted by Prisma Systems for the device "CK QVET". The FDA issued a decision of Substantially Equivalent on March 3, 1995. The device falls under product code CGS (Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes), a Class II device regulated under 21 CFR 862.1215. Prisma Systems has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 3, 1995
Date Received
January 17, 1995
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 Prisma Systems

  • K943027 — CHOLESTEROL QVET (January 27, 1995)
  • K943001 — MAGNESIUM QVET (December 29, 1994)
  • K942963 — GLUCOSE QVET (December 29, 1994)
  • K942964 — LACTATE DEHYDROGENASE QVET (December 29, 1994)
  • K943042 — BUN QVET (December 29, 1994)
  • K942997 — ALKALINE PHOSPHATASE (ALKP) QVET (December 29, 1994)
  • K943000 — ALBUMIN QVET (December 13, 1994)
  • K944102 — AST QVET (December 13, 1994)
  • K943026 — POTASSIUM QVET (December 9, 1994)
  • K942961 — AMYLASE QVET (December 9, 1994)

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