TECH SIMPLE ANTISTREPTOLYSIN O ASO SERUM CONTROL— 510(k) K922723

Name: FDA 510(k) clearance K922723
Creator: U.S. Food and Drug Administration
Published: 1992-09-18

Substantially Equivalent

Simplicity Diagnostics, Inc.

FDA 510(k) clearance K922723 for TECH SIMPLE ANTISTREPTOLYSIN O ASO SERUM CONTROL, Substantially Equivalent on 1992-09-18. Applicant: Simplicity Diagnostics, Inc.. Device class: 1.

Clearance details

Applicant: Simplicity Diagnostics, Inc.
Product code: Code GTQ
Device class: Class 1
Regulation: 21 CFR 866.3720
Advisory panel: Microbiology
Date received: 1992-06-05
Decision date: 1992-09-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hatboro, PA, US

Download summary PDF View on FDA.gov ↗

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