CREATINE KINASE-MB (CK-MB) REAGENT SET— 510(k) K935463

Name: FDA 510(k) clearance K935463
Creator: U.S. Food and Drug Administration
Published: 1994-01-11

Substantially Equivalent

Pointe Scientific, Inc.,

FDA 510(k) clearance K935463 for CREATINE KINASE-MB (CK-MB) REAGENT SET, Substantially Equivalent on 1994-01-11. Applicant: Pointe Scientific, Inc.,. Device class: 2.

Clearance details

Applicant: Pointe Scientific, Inc.,
Product code: Code CGS
Device class: Class 2
Regulation: 21 CFR 862.1215
Advisory panel: Clinical Chemistry
Date received: 1993-11-12
Decision date: 1994-01-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lincoln Park, MI, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code CGS

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K191296 — Pointe Scientific Creatinine Kinase (CK) Reagent Set2020-08-11
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K123977 — RANDOX LIQUID CK-MB, RANDOX CK-MB CALIBRATOR2013-11-21
K112416 — CPK REAGENT2011-11-09

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K070207 — MULTI-ANALYTE CHEMISTRY CALIBRATOR2007-04-13
K070504 — AMMONIA/ALCOHOL CONTROL SET2007-04-11

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