RESUBMITTED EBV/IGM-CHECK TEST KIT— 510(k) K890639

Name: FDA 510(k) clearance K890639
Creator: U.S. Food and Drug Administration
Published: 1989-06-20

Substantially Equivalent

Diagnostic Technology, Inc.

FDA 510(k) clearance K890639 for RESUBMITTED EBV/IGM-CHECK TEST KIT, Substantially Equivalent on 1989-06-20. Applicant: Diagnostic Technology, Inc.. Device class: 1.

Clearance details

Applicant: Diagnostic Technology, Inc.
Product code: Code LJN
Device class: Class 1
Regulation: 21 CFR 866.3235
Advisory panel: Microbiology
Date received: 1989-02-08
Decision date: 1989-06-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hauppauge, NY, US

Download summary PDF View on FDA.gov ↗

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