N-ASSAY CPK-L— 510(k) K980900

Substantially Equivalent

Crestat Diagnostics, Inc.

FDA 510(k) clearance K980900 for N-ASSAY CPK-L, Substantially Equivalent on 1998-03-26. Applicant: Crestat Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Crestat Diagnostics, Inc.
Product code: Code CGS
Device class: Class 2
Regulation: 21 CFR 862.1215
Advisory panel: Clinical Chemistry
Date received: 1998-03-10
Decision date: 1998-03-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seattle, WA, US

Download summary PDF View on FDA.gov ↗

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More clearances from Crestat Diagnostics, Inc.

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K981289 — N-ASSAY L T-BIL1998-04-27
K980902 — N-ASSAY L AST/GOT1998-03-26
K971985 — N-ASSAY TIA PLASMINOGEN TEST KIT1997-10-20

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