FLUORESCENT TREPONEMEL ANTIBODY-ABSORB— 510(k) K843613

Name: FDA 510(k) clearance K843613
Creator: U.S. Food and Drug Administration
Published: 1984-10-31

Substantially Equivalent

Immuno-Products Industries

FDA 510(k) clearance K843613 for FLUORESCENT TREPONEMEL ANTIBODY-ABSORB, Substantially Equivalent on 1984-10-31. Applicant: Immuno-Products Industries. Device class: 2.

Clearance details

Applicant: Immuno-Products Industries
Product code: Code GMS
Device class: Class 2
Regulation: 21 CFR 866.3830
Advisory panel: Microbiology
Date received: 1984-09-10
Decision date: 1984-10-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: So. Bound Brook, NJ, US

Download summary PDF View on FDA.gov ↗

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