N-ASSAY TIA IGA— 510(k) K933971

Substantially Equivalent

Crestat Diagnostics, Inc.

FDA 510(k) clearance K933971 for N-ASSAY TIA IGA, Substantially Equivalent on 1994-03-22. Applicant: Crestat Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Crestat Diagnostics, Inc.
Product code: Code CFN
Device class: Class 2
Regulation: 21 CFR 866.5510
Advisory panel: Immunology
Date received: 1993-08-13
Decision date: 1994-03-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Thousand Oaks, CA, US

Download summary PDF View on FDA.gov ↗

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