ACE CEDIA CORTISOL ASSAY— 510(k) K943427

Name: FDA 510(k) clearance K943427
Creator: U.S. Food and Drug Administration
Published: 1994-11-28

Substantially Equivalent

Schiapparelli Biosystems, Inc.

FDA 510(k) clearance K943427 for ACE CEDIA CORTISOL ASSAY, Substantially Equivalent on 1994-11-28. Applicant: Schiapparelli Biosystems, Inc.. Device class: 2.

Clearance details

Applicant: Schiapparelli Biosystems, Inc.
Product code: Code CGR
Device class: Class 2
Regulation: 21 CFR 862.1205
Advisory panel: Clinical Chemistry
Date received: 1994-07-15
Decision date: 1994-11-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fairfield, NJ, US

Download summary PDF View on FDA.gov ↗

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