SAS(TM) DIRECT MONOCLONAL HCG— 510(k) K935863

Name: FDA 510(k) clearance K935863
Creator: U.S. Food and Drug Administration
Published: 1994-02-24

Substantially Equivalent

Sa Scientific, Inc.

FDA 510(k) clearance K935863 for SAS(TM) DIRECT MONOCLONAL HCG, Substantially Equivalent on 1994-02-24. Applicant: Sa Scientific, Inc.. Device class: 2.

Clearance details

Applicant: Sa Scientific, Inc.
Product code: Code JHJ
Device class: Class 2
Regulation: 21 CFR 862.1155
Advisory panel: Clinical Chemistry
Date received: 1993-12-03
Decision date: 1994-02-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Antonio, TX, US

Download summary PDF View on FDA.gov ↗

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