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510(k) K870733

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 26, 1987
Date Received
February 25, 1987
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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  • K875367 — COLORGENE FLUORESCENT DNA HYBRIDIZATION TEST / CMV (March 28, 1988)
  • K872576 — COLORGENE DNA HYBRIDIZATION TEST CMV CONFIRMATION (December 4, 1987)

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