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510(k) K894624

MUMPS VIRUS by Bion Ent., Ltd. — Product Code GRA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 16, 1989
Date Received
July 20, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antiserum, Fluorescent, Mumps Virus
Device Class
Class I
Regulation Number
866.3380
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)
  • 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)
  • K881261 — BION HSV1-G OR HSV2-G TEST SYSTEM (June 7, 1988)

Other clearances for product code GRA

  • K822826 — ANTIBODY TO MUMPS VIRUS IFA TEST (December 3, 1982)
  • K770216 — VIRAL ANTISERA, FLUORESCEIN LABELED (March 1, 1977)