SR1 DHEA-S ENZYME IMMUNOASSAY— 510(k) K942051

Name: FDA 510(k) clearance K942051
Creator: U.S. Food and Drug Administration
Published: 1994-07-13

Substantially Equivalent

Serono Diagnostics, Inc.

FDA 510(k) clearance K942051 for SR1 DHEA-S ENZYME IMMUNOASSAY, Substantially Equivalent on 1994-07-13. Applicant: Serono Diagnostics, Inc.. Device class: 1.

Clearance details

Applicant: Serono Diagnostics, Inc.
Product code: Code JKC
Device class: Class 1
Regulation: 21 CFR 862.1245
Advisory panel: Clinical Chemistry
Date received: 1994-04-28
Decision date: 1994-07-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Allentown, PA, US

Download summary PDF View on FDA.gov ↗

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