PROLACTIN (PRL) HORMONE MICROPLATE ELISA— 510(k) K971921

Name: FDA 510(k) clearance K971921
Creator: U.S. Food and Drug Administration
Published: 1997-06-24

Substantially Equivalent

Monobind

FDA 510(k) clearance K971921 for PROLACTIN (PRL) HORMONE MICROPLATE ELISA, Substantially Equivalent on 1997-06-24. Applicant: Monobind. Device class: 1.

Clearance details

Applicant: Monobind
Product code: Code CFT
Device class: Class 1
Regulation: 21 CFR 862.1625
Advisory panel: Clinical Chemistry
Date received: 1997-05-23
Decision date: 1997-06-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Costa Mesa, CA, US

Download summary PDF View on FDA.gov ↗

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