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510(k) K875367

COLORGENE FLUORESCENT DNA HYBRIDIZATION TEST / CMV by Enzo Biochem, Inc. — Product Code GQM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 28, 1988
Date Received
December 31, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antisera, Neutralization, Herpesvirus Hominis
Device Class
Class II
Regulation Number
866.3305
Review Panel
MI
Submission Type

Other clearances by Enzo Biochem, Inc.

  • K880604 — COLORGENE HSV DNA HYBRIDIZATION TEST (August 3, 1988)
  • K881907 — HEMAGEL(TM) TEST FOR FECAL OCCULT BLOOD (July 8, 1988)
  • K872576 — COLORGENE DNA HYBRIDIZATION TEST CMV CONFIRMATION (December 4, 1987)
  • K870733 — COLORGENE DNA HYBRIDIZATION TEST FOR HSV CONFIRMA. (May 26, 1987)

Other clearances for product code GQM

  • K810043 — GOAT ANTI-HERPES SIMPLEX VIRUS TYPE I (May 15, 1981)
  • K791397 — HERPES EIA TEST KIT (September 24, 1979)