IMMUNO-PROD IND FLUORE TREPONE ANTIBODY ABSORPED— 510(k) K853122

Name: FDA 510(k) clearance K853122
Creator: U.S. Food and Drug Administration
Published: 1985-09-19

Substantially Equivalent

Immuno-Products Industries

FDA 510(k) clearance K853122 for IMMUNO-PROD IND FLUORE TREPONE ANTIBODY ABSORPED, Substantially Equivalent on 1985-09-19. 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: 1985-07-25
Decision date: 1985-09-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: So. Bound Brook, NJ, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.