CREATINE KINASE MB DETERMINATION (UV)— 510(k) K942958

Name: FDA 510(k) clearance K942958
Creator: U.S. Food and Drug Administration
Published: 1994-11-21

Substantially Equivalent

Biochemical Trade, Inc.

FDA 510(k) clearance K942958 for CREATINE KINASE MB DETERMINATION (UV), Substantially Equivalent on 1994-11-21. Applicant: Biochemical Trade, Inc.. Device class: 2.

Clearance details

Applicant: Biochemical Trade, Inc.
Product code: Code JHW
Device class: Class 2
Regulation: 21 CFR 862.1215
Advisory panel: Clinical Chemistry
Date received: 1994-06-23
Decision date: 1994-11-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miami, FL, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K942958

K-number listed on FDA's recall record

Z-2649-2017 — The Pointe Scientific CK-MB Isoenzyme Control Pointe Scientific CK-MB Level II Control, C7562-12 Control KitClass III·Terminated·Medtest Holdings, Inc.·20101122

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K942958.

Data sourced from openFDA. This site is unofficial and independent of the FDA.