N-ASSAY TIA MICROALBUMIN— 510(k) K934146

Name: FDA 510(k) clearance K934146
Creator: U.S. Food and Drug Administration
Published: 1994-01-11

Substantially Equivalent

Crestat Diagnostics, Inc.

FDA 510(k) clearance K934146 for N-ASSAY TIA MICROALBUMIN, Substantially Equivalent on 1994-01-11. Applicant: Crestat Diagnostics, Inc.. Device class: 1.

Clearance details

Applicant: Crestat Diagnostics, Inc.
Product code: Code JIR
Device class: Class 1
Regulation: 21 CFR 862.1645
Advisory panel: Clinical Chemistry
Date received: 1993-08-24
Decision date: 1994-01-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Thousand Oaks, CA, US

Download summary PDF View on FDA.gov ↗

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