IMMUNOWELL VCA IGM TEST— 510(k) K973939

Substantially Equivalent

Genbio

FDA 510(k) clearance K973939 for IMMUNOWELL VCA IGM TEST, Substantially Equivalent on 1998-08-10. Applicant: Genbio. Device class: 1.

Clearance details

Applicant: Genbio
Product code: Code LJN
Device class: Class 1
Regulation: 21 CFR 866.3235
Advisory panel: Microbiology
Date received: 1997-10-15
Decision date: 1998-08-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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More clearances from Genbio

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K973941 — IMMUNOWELL EBNA IGG TEST1998-08-10

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