(EIA) FOR IGM ANTIBODY TO EBV VCA IN HUMAN SERUM— 510(k) K901840

Name: FDA 510(k) clearance K901840
Creator: U.S. Food and Drug Administration
Published: 1990-09-12

Substantially Equivalent

Granbio, Inc.

FDA 510(k) clearance K901840 for (EIA) FOR IGM 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 LJN
Device class: Class 1
Regulation: 21 CFR 866.3235
Advisory panel: Microbiology
Date received: 1990-04-24
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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K951822 — EBNA ENZYME IMMUNOASSAY KIT1996-02-15
K934774 — UNKNOWN1994-04-20
K901156 — EIA FOR IGG ANTIBODY TO EBV VCA IN HUMAN SERUM1990-09-12
K881617 — INDIRECT IMMUNOFLUORESCENT ANTIBODY ASSAY1988-06-07
K871298 — EBNA ACIF ASSAY KIT1987-06-25

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