LYME-CHECK(TM) TEST KIT— 510(k) K896378

Name: FDA 510(k) clearance K896378
Creator: U.S. Food and Drug Administration
Published: 1991-11-05

Substantially Equivalent

Diagnostic Technology, Inc.

FDA 510(k) clearance K896378 for LYME-CHECK(TM) TEST KIT, Substantially Equivalent on 1991-11-05. Applicant: Diagnostic Technology, Inc.. Device class: 2.

Clearance details

Applicant: Diagnostic Technology, Inc.
Product code: Code LSR
Device class: Class 2
Regulation: 21 CFR 866.3830
Advisory panel: Microbiology
Date received: 1989-11-06
Decision date: 1991-11-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hauppauge, NY, US

Download summary PDF View on FDA.gov ↗

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