SERODOT CMV (CYTOMEGALOVIRUS) IGG TEST KIT— 510(k) K875361

Name: FDA 510(k) clearance K875361
Creator: U.S. Food and Drug Administration
Published: 1988-05-13

Substantially Equivalent

Disease Detection International, Inc.

FDA 510(k) clearance K875361 for SERODOT CMV (CYTOMEGALOVIRUS) IGG TEST KIT, Substantially Equivalent on 1988-05-13. Applicant: Disease Detection International, Inc.. Device class: 2.

Clearance details

Applicant: Disease Detection International, Inc.
Product code: Code LFZ
Device class: Class 2
Regulation: 21 CFR 866.3175
Advisory panel: Microbiology
Date received: 1987-12-31
Decision date: 1988-05-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

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