ANTISTREPTOLYSIN (ASO) LATEX SLIDE TEST— 510(k) K790831

Name: FDA 510(k) clearance K790831
Creator: U.S. Food and Drug Administration
Published: 1979-06-15

Substantially Equivalent

Icl Scientific

FDA 510(k) clearance K790831 for ANTISTREPTOLYSIN (ASO) LATEX SLIDE TEST, Substantially Equivalent on 1979-06-15. Applicant: Icl Scientific. Device class: 1.

Clearance details

Applicant: Icl Scientific
Product code: Code GTQ
Device class: Class 1
Regulation: 21 CFR 866.3720
Advisory panel: Microbiology
Date received: 1979-04-30
Decision date: 1979-06-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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K926236 — BECKMAN ANTI-STREPTOLYSIN O KIT1993-06-15
K924247 — ACCUTEX ASO LATEX TEST1992-12-07

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