T4 SEROZYME ENZYMEIMMUNOASSAY KIT/MAG. SOLID PHASE— 510(k) K874866

Name: FDA 510(k) clearance K874866
Creator: U.S. Food and Drug Administration
Published: 1988-02-11

Substantially Equivalent

Serono Diagnostics, Inc.

FDA 510(k) clearance K874866 for T4 SEROZYME ENZYMEIMMUNOASSAY KIT/MAG. SOLID PHASE, Substantially Equivalent on 1988-02-11. Applicant: Serono Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Serono Diagnostics, Inc.
Product code: Code KLI
Device class: Class 2
Regulation: 21 CFR 862.1700
Advisory panel: Clinical Chemistry
Date received: 1987-11-27
Decision date: 1988-02-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Norwell, MA, US

Download summary PDF View on FDA.gov ↗

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