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510(k) K872576

COLORGENE DNA HYBRIDIZATION TEST CMV CONFIRMATION by Enzo Biochem, Inc. — Product Code GQH

K872576 is an FDA 510(k) premarket notification submitted by Enzo Biochem, Inc. for the device "COLORGENE DNA HYBRIDIZATION TEST CMV CONFIRMATION". The FDA issued a decision of Substantially Equivalent on December 4, 1987. The device falls under product code GQH (Antigen, Cf (Including Cf Control), Cytomegalovirus), a Class II device regulated under 21 CFR 866.3175. Enzo Biochem, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 4, 1987
Date Received
June 30, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antigen, Cf (Including Cf Control), Cytomegalovirus
Device Class
Class II
Regulation Number
866.3175
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)
  • K875367 — COLORGENE FLUORESCENT DNA HYBRIDIZATION TEST / CMV (March 28, 1988)
  • K870733 — COLORGENE DNA HYBRIDIZATION TEST FOR HSV CONFIRMA. (May 26, 1987)

Other clearances for product code GQH

  • K982311 — BARTELS CINAKIT CMV ANTIGENEMIA (December 14, 1998)
  • K964875 — CMV ANTIGEN CONTROL SLIDES (March 18, 1997)
  • K935809 — CYTOMEGALOVIRUS INDIRECT IMMUNOFLUORESCENCE ASSAY (May 5, 1994)
  • K882835 — INDIRECT FLUORESCENT ASSAY FOR (HCMV) (December 5, 1988)
  • K882024 — FITC MURINE MONOCLONAL ANTI-CMV IGG (August 3, 1988)
  • K881932 — ORTHO* CYTOMEGALOVIRUS IDENTIFICATION REAGENT (August 1, 1988)
  • K880679 — BION CMV-G TEST SYSTEM (June 3, 1988)
  • K880290 — MICROTRAK CMV CULTURE CONFIRMATION TEST (April 19, 1988)
  • K873114 — CYTOMEGALOVIRUS CONTROL SLIDES (September 25, 1987)
  • K864565 — MONABRITE CYTOMEGALOVIRUS (CMV) IFA KIT (February 19, 1987)

FDA data resources