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510(k) K874863

RAMP HERPES SIMPLEX VIRUS (HSV) (CCT) by Monoclonal Antibodies, Inc. — Product Code GQN

K874863 is an FDA 510(k) premarket notification submitted by Monoclonal Antibodies, Inc. for the device "RAMP HERPES SIMPLEX VIRUS (HSV) (CCT)". The FDA issued a decision of Substantially Equivalent on February 16, 1988. 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. Monoclonal Antibodies, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 16, 1988
Date Received
November 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 Monoclonal Antibodies, Inc.

  • K871726 — OVUQUICK SELF-TEST (OVUQUICK; RAMP LH ASSAY) (July 27, 1987)
  • K863744 — HCG CONTROL KIT (November 5, 1986)
  • K860924 — RAMP PROGESTURINE PDG ASSAY--48 TEST KIT (July 2, 1986)
  • K854611 — RAMP URINE HCG ASSAY (December 30, 1985)
  • K850730 — MODEL SERUM HCG ASSAY (April 2, 1985)
  • K850480 — OVU STICK SELF-TEST -MODIFICATION (March 5, 1985)
  • K843284 — OVUSTICK SELF-TEST (December 11, 1984)
  • K840738 — PLUS URINE HCG ASSAY (April 19, 1984)
  • K840412 — OVU STICK URINE HLH KIT (April 13, 1984)
  • K833504 — PREGNASTICK URINE HCG KIT (January 9, 1984)

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