CREATINE KINASE (CK)— 510(k) K972155

Clearance details

Applicant

Stanbio Laboratory

Product code

Code CGS

Device class

Class 2

Regulation

21 CFR 862.1215

Advisory panel

Clinical Chemistry

Date received

1997-06-05

Decision date

1997-07-17

Decision

Substantially Equivalent

Clearance type

Traditional

Location

San Antonio, TX, US

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• Z-2650-2017 — Pointe Scientific Liquid Creatine Kinase Reagent Set Device is a kit comprised of two reagents an R 1 Buffer and R2 CK enzyme solution. Intended Use: For the kinetic quantitative determination of creatine kinase activity in serum.Class III·Terminated·Medtest Holdings, Inc.·20111019

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K972155.