SR1 T3 UPTAKE ENZYME IMMUNOASSAY(MAG SOLID-PHASE)— 510(k) K911912

Name: FDA 510(k) clearance K911912
Creator: U.S. Food and Drug Administration
Published: 1991-09-18

Substantially Equivalent

Serono-Baker Diagnostics, Inc.

FDA 510(k) clearance K911912 for SR1 T3 UPTAKE ENZYME IMMUNOASSAY(MAG SOLID-PHASE), Substantially Equivalent on 1991-09-18. Applicant: Serono-Baker Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Serono-Baker Diagnostics, Inc.
Product code: Code KHQ
Device class: Class 2
Regulation: 21 CFR 862.1715
Advisory panel: Clinical Chemistry
Date received: 1991-04-30
Decision date: 1991-09-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Allentown, PA, US

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