CIBA CORNING ACS FSH IMMUNOASSAY— 510(k) K904649

Name: FDA 510(k) clearance K904649
Creator: U.S. Food and Drug Administration
Published: 1990-11-20

Substantially Equivalent

Ciba Corning Diagnostics Corp.

FDA 510(k) clearance K904649 for CIBA CORNING ACS FSH IMMUNOASSAY, Substantially Equivalent on 1990-11-20. Applicant: Ciba Corning Diagnostics Corp.. Device class: 1.

Clearance details

Applicant: Ciba Corning Diagnostics Corp.
Product code: Code CGJ
Device class: Class 1
Regulation: 21 CFR 862.1300
Advisory panel: Clinical Chemistry
Date received: 1990-10-11
Decision date: 1990-11-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: East Walpole, MA, US

Download summary PDF View on FDA.gov ↗

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