COLORGENE FLUORESCENT DNA HYBRIDIZATION TEST / CMV— 510(k) K875367

Name: FDA 510(k) clearance K875367
Creator: U.S. Food and Drug Administration
Published: 1988-03-28

Substantially Equivalent

Enzo Biochem, Inc.

FDA 510(k) clearance K875367 for COLORGENE FLUORESCENT DNA HYBRIDIZATION TEST / CMV, Substantially Equivalent on 1988-03-28. Applicant: Enzo Biochem, Inc.. Device class: 2.

Clearance details

Applicant: Enzo Biochem, Inc.
Product code: Code GQM
Device class: Class 2
Regulation: 21 CFR 866.3305
Advisory panel: Microbiology
Date received: 1987-12-31
Decision date: 1988-03-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New York, NY, US

Download summary PDF View on FDA.gov ↗

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