CHLAMYDIA-CHECK(TM) DIRECT & CULTURE CONFIR. KIT— 510(k) K864128

Name: FDA 510(k) clearance K864128
Creator: U.S. Food and Drug Administration
Published: 1987-04-29

Substantially Equivalent

Diagnostic Technology, Inc.

FDA 510(k) clearance K864128 for CHLAMYDIA-CHECK(TM) DIRECT & CULTURE CONFIR. KIT, Substantially Equivalent on 1987-04-29. Applicant: Diagnostic Technology, Inc.. Device class: 1.

Clearance details

Applicant: Diagnostic Technology, Inc.
Product code: Code LJP
Device class: Class 1
Regulation: 21 CFR 866.3120
Advisory panel: Microbiology
Date received: 1986-10-21
Decision date: 1987-04-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hauppauge, NY, US

Download summary PDF View on FDA.gov ↗

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