VISIBLE-CHLAMYDIA(TM) TEST SYSTEM— 510(k) K862638

Substantially Equivalent

Isolab, Inc.

FDA 510(k) clearance K862638 for VISIBLE-CHLAMYDIA(TM) TEST SYSTEM, Substantially Equivalent on 1986-08-26. Applicant: Isolab, Inc.. Device class: 1.

Clearance details

Applicant: Isolab, Inc.
Product code: Code LJC
Device class: Class 1
Regulation: 21 CFR 866.3120
Advisory panel: Microbiology
Date received: 1986-07-10
Decision date: 1986-08-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Akron, OH, US

Download summary PDF View on FDA.gov ↗

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