INDIRECT ENZYME LINKED IMMUNOSORBENT ASSAY IGG ANT— 510(k) K853484

Name: FDA 510(k) clearance K853484
Creator: U.S. Food and Drug Administration
Published: 1986-02-05

Substantially Equivalent

Biotech Research Laboratories, Inc.

FDA 510(k) clearance K853484 for INDIRECT ENZYME LINKED IMMUNOSORBENT ASSAY IGG ANT, Substantially Equivalent on 1986-02-05. Applicant: Biotech Research Laboratories, Inc.. Device class: 1.

Clearance details

Applicant: Biotech Research Laboratories, Inc.
Product code: Code GNP
Device class: Class 1
Regulation: 21 CFR 866.3235
Advisory panel: Microbiology
Date received: 1985-08-20
Decision date: 1986-02-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rockville, MD, US

Download summary PDF View on FDA.gov ↗

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