EBV VCA IGM ANTIBODY ASSAY KIT— 510(k) K864604

Substantially Equivalent

Granbio, Inc.

FDA 510(k) clearance K864604 for EBV VCA IGM ANTIBODY ASSAY KIT, Substantially Equivalent on 1987-02-02. 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: 1986-11-24
Decision date: 1987-02-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Temecula, CA, US

Download summary PDF View on FDA.gov ↗

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More clearances from Granbio, Inc.

K951822 — EBNA ENZYME IMMUNOASSAY KIT1996-02-15
K934774 — UNKNOWN1994-04-20
K901156 — EIA FOR IGG ANTIBODY TO EBV VCA IN HUMAN SERUM1990-09-12
K901840 — (EIA) FOR IGM ANTIBODY TO EBV VCA IN HUMAN SERUM1990-09-12
K881617 — INDIRECT IMMUNOFLUORESCENT ANTIBODY ASSAY1988-06-07

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