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510(k) K870733

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

K870733 is an FDA 510(k) premarket notification submitted by Enzo Biochem, Inc. for the device "COLORGENE DNA HYBRIDIZATION TEST FOR HSV CONFIRMA.". The FDA issued a decision of Substantially Equivalent on May 26, 1987. The device falls under product code GQN (Antigen, Cf (Including Cf Control), Herpesvirus Hominis 1,2), a Class II device regulated under 21 CFR 866.3305. Enzo Biochem, Inc. has at least 4 other 510(k) clearances on record.

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.

  • 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)
  • K872576 — COLORGENE DNA HYBRIDIZATION TEST CMV CONFIRMATION (December 4, 1987)

Other clearances for product code GQN

  • K070265 — DIAGNOSTIC HYBRIDS' D3 DFA HERPES SIMPLEX VIRUS IDENTIFICATION AND TYPING KIT, M (October 24, 2007)
  • K063798 — DIAGNOSTIC HYBRIDS' D3 DFA HERPES SIMPLEX VIRUS IDENTIFICATION KIT, MODEL 01-080 (September 21, 2007)
  • K991880 — LIGHT DIAGNOSTICS SIMULFLUOR HSV 1/2 IMMUNOFLUORECENCE ASSAY (November 9, 1999)
  • K971662 — ELVIS HSV ID/TYPING TEST SYSTEM (November 18, 1997)
  • K971101 — HSV-2 ANTIGEN CONTROL SLIDES (July 1, 1997)
  • K964874 — HSV-1 ANTIGEN CONTROL SLIDES (July 1, 1997)
  • K960578 — ELVIS HSV GOLD (September 5, 1996)
  • K941924 — ELVIS HSV (May 1, 1995)
  • K911345 — HSV IN SITU DNA PROBE HYBRIDIZATION TEST KIT (June 17, 1991)
  • K884761 — MODIFIED CELL-MATICS HERPES SIMPLEX VIRUS DETECT. (December 5, 1988)

FDA data resources