PRL SEROZYME IMMUNOENZ. ASSAY KIT, MAG. SOLID PHAS— 510(k) K872862

Name: FDA 510(k) clearance K872862
Creator: U.S. Food and Drug Administration
Published: 1987-09-18

Substantially Equivalent

Serono Diagnostics, Inc.

FDA 510(k) clearance K872862 for PRL SEROZYME IMMUNOENZ. ASSAY KIT, MAG. SOLID PHAS, Substantially Equivalent on 1987-09-18. Applicant: Serono Diagnostics, Inc.. Device class: 1.

Clearance details

Applicant: Serono Diagnostics, Inc.
Product code: Code CFT
Device class: Class 1
Regulation: 21 CFR 862.1625
Advisory panel: Clinical Chemistry
Date received: 1987-07-21
Decision date: 1987-09-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Norwell, MA, US

Download summary PDF View on FDA.gov ↗

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