CHLAMYDIA TISSUE CULTURE CONFIRMATION TEST (EIA)— 510(k) K862948

Name: FDA 510(k) clearance K862948
Creator: U.S. Food and Drug Administration
Published: 1986-10-17

Substantially Equivalent

Intercare Diagnostics, Inc.

FDA 510(k) clearance K862948 for CHLAMYDIA TISSUE CULTURE CONFIRMATION TEST (EIA), Substantially Equivalent on 1986-10-17. Applicant: Intercare Diagnostics, Inc.. Device class: 1.

Clearance details

Applicant: Intercare Diagnostics, Inc.
Product code: Code LJC
Device class: Class 1
Regulation: 21 CFR 866.3120
Advisory panel: Microbiology
Date received: 1986-08-05
Decision date: 1986-10-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Berkeley, CA, US

Download summary PDF View on FDA.gov ↗

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