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510(k) K841245

ENZYGNOST ANTIHERPES SIMPLEX VIRUS by Behring Diagnostics, Inc. — Product Code GQO

K841245 is an FDA 510(k) premarket notification submitted by Behring Diagnostics, Inc. for the device "ENZYGNOST ANTIHERPES SIMPLEX VIRUS". The FDA issued a decision of Substantially Equivalent on November 5, 1985. The device falls under product code GQO (Antisera, Cf, Herpesvirus Hominis 1,2), a Class II device regulated under 21 CFR 866.3305. Behring Diagnostics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 5, 1985
Date Received
March 23, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by Behring Diagnostics, Inc.

  • K973832 — OPUS HLH CONTROLS (October 27, 1997)
  • K972929 — N ANTISERUM TO HUMAN ALBUMIN (October 20, 1997)
  • K972840 — N ANTISERUM TO HUMAN TRANSFERRIN (October 17, 1997)
  • K973202 — MODIFICATION OF OPUS FERRITIN TEST SYSTEM (September 12, 1997)
  • K972316 — OPUS D-DIMER (September 9, 1997)
  • K972116 — VON WILLEBRAND REAGENT (July 25, 1997)
  • K972011 — OPUS ETHANOL (July 22, 1997)
  • K971596 — EMIT II OPIATES 300/2000 ASSAY (June 25, 1997)
  • K971600 — EMIT CALIBRATOR B LEVEL 1 (CUTOFF)/EMIT CALIBRATOR B LEVEL 2 (HIGH) (June 25, 1997)
  • K964595 — OPUS PSA TEST SYSTEM (June 24, 1997)

Other clearances for product code GQO

  • K883281 — VIRGO HSV-2 IGG ELISA (March 10, 1989)
  • K883282 — VIRGO HSV-1 IGG ELISA (March 10, 1989)
  • K881261 — BION HSV1-G OR HSV2-G TEST SYSTEM (June 7, 1988)
  • K875366 — THE DDI SERODOT HERPES IGG TEST KIT (May 23, 1988)
  • K871426 — VIROGEN HSV ANTIBODY TEST (October 15, 1987)
  • K861120 — THE GOLDEN QUAD TEST (HSV) (February 2, 1987)
  • K854712 — VISIBLE-HERPES TM TEST SYSTEM (May 20, 1986)
  • K852782 — HSVI - IGG ELISA-KIT (January 21, 1986)
  • K852781 — HSV2 - IGG ELISA-KIT (January 21, 1986)
  • K842663 — ANTI-HERPES SIMPLEX VIRUS TYPE 1 OR 2 (December 6, 1985)

FDA data resources