Home / 510(k) Clearances / K894623

510(k) K894623

RESPIRATORY SYNCYTIAL VIRUS by Bion Ent., Ltd. — Product Code LKT

K894623 is an FDA 510(k) premarket notification submitted by Bion Ent., Ltd. for the device "RESPIRATORY SYNCYTIAL VIRUS". The FDA issued a decision of Substantially Equivalent on October 16, 1989. The device falls under product code LKT (Respiratory Syncytial Virus, Antigen, Antibody, Ifa), a Class I device regulated under 21 CFR 866.3480. Bion Ent., Ltd. has at least 10 other 510(k) clearances on record.

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
Respiratory Syncytial Virus, Antigen, Antibody, Ifa
Device Class
Class I
Regulation Number
866.3480
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)
  • 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)
  • K881261 — BION HSV1-G OR HSV2-G TEST SYSTEM (June 7, 1988)

Other clearances for product code LKT

  • K081928 — D3 DUET DFA RSV/RESPIRATORY VIRUS SCREENING KIT (December 23, 2008)
  • K983336 — PATHODX RESPIRATORY VIRUS PANEL MODEL PKRP1 (March 18, 1999)
  • K943317 — PATHODX RESPIRATORY SYNCYTIAL VIRUS (RSV) (December 19, 1994)
  • K942173 — RSV ANTIGEN TEST (June 30, 1994)
  • K912842 — RSV-MAB TEST (December 9, 1991)
  • K912838 — BARTELS RESPIRATORY SYNCYTIAL VIRUS ENZYME IMMUNO (September 27, 1991)
  • K912371 — BIOMERIEUX RSV DIRECT IF KIT (September 23, 1991)
  • K884192 — RSV IFA TEST KIT FOR DIRECT ANTIGEN DETECTION (November 22, 1988)
  • K882687 — ANTI-RESPIRATORY SYNCYTIAL VIRUS ANTIBODY TEST (August 30, 1988)
  • K873564 — GENETIC SYSTEMS RSV REAGENT CONTROL SLIDES (November 20, 1987)

FDA data resources