Home / 510(k) Clearances / K830971

510(k) K830971

HERPES SIMPLEX VIRUS TYPING REAGENTS by Immulok, Inc. — Product Code GQL

K830971 is an FDA 510(k) premarket notification submitted by Immulok, Inc. for the device "HERPES SIMPLEX VIRUS TYPING REAGENTS". The FDA issued a decision of Substantially Equivalent on June 30, 1983. The device falls under product code GQL (Antisera, Fluorescent, Herpesvirus Hominis 1,2), a Class II device regulated under 21 CFR 866.3305. Immulok, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 30, 1983
Date Received
March 28, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antisera, Fluorescent, Herpesvirus Hominis 1,2
Device Class
Class II
Regulation Number
866.3305
Review Panel
MI
Submission Type

Other clearances by Immulok, Inc.

  • K830342 — CULUTURE SET CHLAMYDIA ISOLATION AND (May 4, 1983)
  • K830250 — CVT VIRAL TRANSPORTS (February 28, 1983)
  • K823304 — RIASET PROLACTIN RIA KIT (December 22, 1982)
  • K822785 — FLUOROSET IMMUNOFLUORESCENT ANTIBODY (November 29, 1982)
  • K823055 — FLOUROSET IMMUNOFLUORESCENT ANTIBODY (November 5, 1982)
  • K822606 — CYTOMEGALOVIRUS ANTOBODY IGG (November 1, 1982)
  • K822605 — TOXOPLASMA GONDII ANTIBODY IGG (October 27, 1982)
  • K822607 — ANTINUCLEAR ANTOBODY CELL SUBSTRATE (September 17, 1982)
  • K821411 — HISTOSET IMMUNOPEROFIDASE TISSUE (June 25, 1982)
  • K821567 — IMMULOK CULTURESET (June 25, 1982)

Other clearances for product code GQL

  • K091753 — ELVIS HSV ID AND D3 TYPING TEST SYSTEM (August 28, 2009)
  • K081527 — LIGHT DIAGNOSTICS HSV 1/2 TYPING DFA KIT (April 1, 2009)
  • K984120 — THE APTUS(AUTOMATED) APPLICATION OF THE HSV-2 IGG ELISA TEST SYSTEM. AN ENZYME L (May 26, 1999)
  • K984135 — THE APTUS (AUTOMATED) APPLICATION OF THE HSV-1 IGG ELISA TEST SYSTEM. AN ENZYME (May 26, 1999)
  • K905608 — INDIRECT FLUORESCENT ASSAY FOR HERPES SIMPLEX 1 (November 7, 1991)
  • K904095 — HERPES SIMPLEX VIRUS TISSUE CULTURE CONF. TYPING (February 1, 1991)
  • K904167 — PATHODX HERPES TYPING (December 13, 1990)
  • K902662 — BARTELS HERPES SIMPLEX VIR FLU MONO ANTIBODY TEST (July 31, 1990)
  • K902661 — BARTELS HERPES SIMPLEX VIR FLU MONO ANTIB HSV-1&2 (July 31, 1990)
  • K891782 — HSV-2 ELISA TEST SYSTEM (June 20, 1989)

FDA data resources