MMUNO DOT BORRELIA DOT BLOT M TEST— 510(k) K953683

Substantially Equivalent

Genbio

FDA 510(k) clearance K953683 for MMUNO DOT BORRELIA DOT BLOT M TEST, Substantially Equivalent on 1996-05-03. Applicant: Genbio. Device class: 2.

Clearance details

Applicant: Genbio
Product code: Code LSR
Device class: Class 2
Regulation: 21 CFR 866.3830
Advisory panel: Microbiology
Date received: 1995-08-07
Decision date: 1996-05-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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