Home / 510(k) Clearances / K811021

510(k) K811021

HERPES by Immuno-Diagnostic Products, Inc. — Product Code GQN

K811021 is an FDA 510(k) premarket notification submitted by Immuno-Diagnostic Products, Inc. for the device "HERPES". The FDA issued a decision of Substantially Equivalent on November 5, 1981. 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. Immuno-Diagnostic Products, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 5, 1981
Date Received
April 15, 1981
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 Immuno-Diagnostic Products, Inc.

  • K854207 — EBV(EPSTEIN-BARR VIRUS) TEST KIT (April 24, 1986)
  • K811562 — TOXOPLASMOSIS TEST KIT (July 16, 1981)
  • K811022 — ANA TEST KIT (April 23, 1981)
  • K801959 — FTA-ABS TEST (October 23, 1980)
  • K801963 — CMV TEST KIT (October 23, 1980)
  • K801961 — RF-II TEST KIT (October 10, 1980)
  • K801960 — ANTI-DS/N-DNA TEST KIT (October 10, 1980)

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