ASO QUANTUM, ANTISTREPTOLYSIN O TEST— 510(k) K801177

Name: FDA 510(k) clearance K801177
Creator: U.S. Food and Drug Administration
Published: 1980-07-08

Substantially Equivalent

Sclavo, Inc.

FDA 510(k) clearance K801177 for ASO QUANTUM, ANTISTREPTOLYSIN O TEST, Substantially Equivalent on 1980-07-08. Applicant: Sclavo, Inc.. Device class: 1.

Clearance details

Applicant: Sclavo, Inc.
Product code: Code GTQ
Device class: Class 1
Regulation: 21 CFR 866.3720
Advisory panel: Microbiology
Date received: 1980-05-16
Decision date: 1980-07-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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