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510(k) K880604

COLORGENE HSV DNA HYBRIDIZATION TEST by Enzo Biochem, Inc. — Product Code GQN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 3, 1988
Date Received
February 12, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antigen, Cf (Including Cf Control), Herpesvirus Hominis 1,2
Device Class
Class II
Regulation Number
866.3305
Review Panel
MI
Submission Type

Other clearances by Enzo Biochem, Inc.

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  • K872576 — COLORGENE DNA HYBRIDIZATION TEST CMV CONFIRMATION (December 4, 1987)
  • K870733 — COLORGENE DNA HYBRIDIZATION TEST FOR HSV CONFIRMA. (May 26, 1987)

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