N-ASSAY L T-BIL— 510(k) K981289

Substantially Equivalent

Crestat Diagnostics, Inc.

FDA 510(k) clearance K981289 for N-ASSAY L T-BIL, Substantially Equivalent on 1998-04-27. Applicant: Crestat Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Crestat Diagnostics, Inc.
Product code: Code CIG
Device class: Class 2
Regulation: 21 CFR 862.1110
Advisory panel: Clinical Chemistry
Date received: 1998-04-08
Decision date: 1998-04-27
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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