VISIBLE-HERPES TM TEST SYSTEM— 510(k) K854712

Substantially Equivalent

Isolab, Inc.

FDA 510(k) clearance K854712 for VISIBLE-HERPES TM TEST SYSTEM, Substantially Equivalent on 1986-05-20. Applicant: Isolab, Inc.. Device class: 2.

Clearance details

Applicant: Isolab, Inc.
Product code: Code GQO
Device class: Class 2
Regulation: 21 CFR 866.3305
Advisory panel: Microbiology
Date received: 1985-11-22
Decision date: 1986-05-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Akron, OH, US

Download summary PDF View on FDA.gov ↗

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