ACCESS PROLACTIN— 510(k) K941175

Substantially Equivalent

Bio-Rad Laboratories, Inc.

FDA 510(k) clearance K941175 for ACCESS PROLACTIN, Substantially Equivalent on 1994-06-02. Applicant: Bio-Rad Laboratories, Inc.. Device class: 1.

Clearance details

Applicant: Bio-Rad Laboratories, Inc.
Product code: Code CFT
Device class: Class 1
Regulation: 21 CFR 862.1625
Advisory panel: Clinical Chemistry
Date received: 1994-03-14
Decision date: 1994-06-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chaska, MN, US

Download summary PDF View on FDA.gov ↗

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