N-ASSAY TIA ALPHA-1-ANTITRYPSIN TEST KIT— 510(k) K965100

Substantially Equivalent

Crestat Diagnostics, Inc.

FDA 510(k) clearance K965100 for N-ASSAY TIA ALPHA-1-ANTITRYPSIN TEST KIT, Substantially Equivalent on 1997-07-14. Applicant: Crestat Diagnostics, Inc..

Clearance details

Applicant: Crestat Diagnostics, Inc.
Product code: Code DEM
Advisory panel: Immunology
Date received: 1996-12-20
Decision date: 1997-07-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Weston, CT, US

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