ELECSYS PROLACTIN ASSAY— 510(k) K964748

Name: FDA 510(k) clearance K964748
Creator: U.S. Food and Drug Administration
Published: 1997-01-21

Substantially Equivalent

Boehringer Mannheim Corp.

FDA 510(k) clearance K964748 for ELECSYS PROLACTIN ASSAY, Substantially Equivalent on 1997-01-21. Applicant: Boehringer Mannheim Corp.. Device class: 1.

Clearance details

Applicant: Boehringer Mannheim Corp.
Product code: Code CFT
Device class: Class 1
Regulation: 21 CFR 862.1625
Advisory panel: Clinical Chemistry
Date received: 1996-11-26
Decision date: 1997-01-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Concord, CA, US

Download summary PDF View on FDA.gov ↗

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