AGGLUTINOTEST-SYPHILIS— 510(k) K791457

Name: FDA 510(k) clearance K791457
Creator: U.S. Food and Drug Administration
Published: 1979-09-24

Substantially Equivalent

Volu Sol Medical Industries

FDA 510(k) clearance K791457 for AGGLUTINOTEST-SYPHILIS, Substantially Equivalent on 1979-09-24. Applicant: Volu Sol Medical Industries. Device class: 2.

Clearance details

Applicant: Volu Sol Medical Industries
Product code: Code GMT
Device class: Class 2
Regulation: 21 CFR 866.3830
Advisory panel: Microbiology
Date received: 1979-08-06
Decision date: 1979-09-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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