ELISA-DOXA SM/RNP— 510(k) K924948

Name: FDA 510(k) clearance K924948
Creator: U.S. Food and Drug Administration
Published: 1993-05-19

Substantially Equivalent

Advanced Biological Products, Inc.

FDA 510(k) clearance K924948 for ELISA-DOXA SM/RNP, Substantially Equivalent on 1993-05-19. Applicant: Advanced Biological Products, Inc.. Device class: 2.

Clearance details

Applicant: Advanced Biological Products, Inc.
Product code: Code LLL
Device class: Class 2
Regulation: 21 CFR 866.5100
Advisory panel: Immunology
Date received: 1992-09-30
Decision date: 1993-05-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hatboro, PA, US

Download summary PDF View on FDA.gov ↗

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