Home / 510(k) Clearances / K851635

510(k) K851635

DIAGNON HERPES IMMUNOPEROXIDASE TYPING TEST by Diagnon Corp. — Product Code GQL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 10, 1985
Date Received
April 18, 1985
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 Diagnon Corp.

  • K860967 — VIRTRAN VIRAL TRANSPORTER (MODIFIED) (April 4, 1986)
  • K851377 — DIAGNON MONOCOMBO VITAM. B12[57CO]/FOLATE[125I] RA (August 21, 1985)
  • K851378 — VIRTRAN VIRAL TRANPORTER (June 21, 1985)
  • K841302 — DIAGNON FOLATE 125I RIA KIT (June 22, 1984)
  • K832717 — DIAGNON B12 57CO RIA KIT (December 8, 1983)

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)
  • K984135 — THE APTUS (AUTOMATED) APPLICATION OF THE HSV-1 IGG ELISA TEST SYSTEM. AN ENZYME (May 26, 1999)
  • K984120 — THE APTUS(AUTOMATED) APPLICATION OF THE HSV-2 IGG ELISA TEST SYSTEM. AN ENZYME L (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)
  • K902661 — BARTELS HERPES SIMPLEX VIR FLU MONO ANTIB HSV-1&2 (July 31, 1990)
  • K902662 — BARTELS HERPES SIMPLEX VIR FLU MONO ANTIBODY TEST (July 31, 1990)
  • K891162 — HSV-1 ELISA TEST SYSTEM (June 20, 1989)