EIA FOR IGG ANTIBODY TO EBV VCA IN HUMAN SERUM— 510(k) K901156

Name: FDA 510(k) clearance K901156
Creator: U.S. Food and Drug Administration
Published: 1990-09-12

Substantially Equivalent

Granbio, Inc.

FDA 510(k) clearance K901156 for EIA FOR IGG ANTIBODY TO EBV VCA IN HUMAN SERUM, Substantially Equivalent on 1990-09-12. Applicant: Granbio, Inc.. Device class: 1.

Clearance details

Applicant: Granbio, Inc.
Product code: Code GNP
Device class: Class 1
Regulation: 21 CFR 866.3235
Advisory panel: Microbiology
Date received: 1990-03-13
Decision date: 1990-09-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Temecula, CA, US

Download summary PDF View on FDA.gov ↗

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K881617 — INDIRECT IMMUNOFLUORESCENT ANTIBODY ASSAY1988-06-07
K871298 — EBNA ACIF ASSAY KIT1987-06-25

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