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510(k) K881261

BION HSV1-G OR HSV2-G TEST SYSTEM by Bion Ent., Ltd. — Product Code GQO

K881261 is an FDA 510(k) premarket notification submitted by Bion Ent., Ltd. for the device "BION HSV1-G OR HSV2-G TEST SYSTEM". The FDA issued a decision of Substantially Equivalent on June 7, 1988. The device falls under product code GQO (Antisera, Cf, Herpesvirus Hominis 1,2), a Class II device regulated under 21 CFR 866.3305. Bion Ent., Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 7, 1988
Date Received
March 24, 1988
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 Bion Ent., Ltd.

  • K926066 — BION MUMPS-G ANTIBODY TEST SYSTEM (June 15, 1993)
  • K901054 — BION BORRELIA BURGDORFERI ANTIGEN SUBSTRATE SLIDE (April 5, 1990)
  • K894622 — VARICELLA ZOSTER VIRUS (October 24, 1989)
  • K894623 — RESPIRATORY SYNCYTIAL VIRUS (October 16, 1989)
  • K894626 — EPSTEIN-BARR VIRUS-NUCLEAR ANTIGEN (October 16, 1989)
  • K894624 — MUMPS VIRUS (October 16, 1989)
  • K891785 — BION EBV-G (VCA) TEST SYSTEM (August 31, 1989)
  • K894625 — CHLAMYDIA (LGV-1) (August 15, 1989)
  • K893240 — BION EBV-M (VCA) TEST SYSTEM (July 14, 1989)
  • K890616 — BION DIRECT IDENTIFICATION CONTROL SLIDE (February 17, 1989)

Other clearances for product code GQO

  • K883282 — VIRGO HSV-1 IGG ELISA (March 10, 1989)
  • K883281 — VIRGO HSV-2 IGG ELISA (March 10, 1989)
  • 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)
  • K852781 — HSV2 - IGG ELISA-KIT (January 21, 1986)
  • K852782 — HSVI - IGG ELISA-KIT (January 21, 1986)
  • K842531 — AMIZYME-HSV TYPES 1 & 2 TEST KITS (December 6, 1985)
  • K842663 — ANTI-HERPES SIMPLEX VIRUS TYPE 1 OR 2 (December 6, 1985)

FDA data resources