N-ASSAY TIA C4 TEST KIT— 510(k) K964297

Substantially Equivalent

Crestat Diagnostics, Inc.

FDA 510(k) clearance K964297 for N-ASSAY TIA C4 TEST KIT, Substantially Equivalent on 1997-07-14. Applicant: Crestat Diagnostics, Inc..

Clearance details

Applicant: Crestat Diagnostics, Inc.
Product code: Code DBI
Advisory panel: Immunology
Date received: 1996-10-29
Decision date: 1997-07-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Murrieta, CA, US

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.