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510(k) K965092

VIDAS ROTAVIRUS ASSAY by Biomerieux Vitek, Inc. — Product Code LIQ

K965092 is an FDA 510(k) premarket notification submitted by Biomerieux Vitek, Inc. for the device "VIDAS ROTAVIRUS ASSAY". The FDA issued a decision of Substantially Equivalent on May 5, 1997. The device falls under product code LIQ (Enzyme Linked Immunoabsorbent Assay, Rotavirus), a Class I device regulated under 21 CFR 866.3405. Biomerieux Vitek, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 5, 1997
Date Received
December 19, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Linked Immunoabsorbent Assay, Rotavirus
Device Class
Class I
Regulation Number
866.3405
Review Panel
MI
Submission Type

Other clearances by Biomerieux Vitek, Inc.

  • K973819 — VIDAS D-DIMER (DD) ASSAY (March 10, 1998)
  • K972895 — VIDAS ROTAVIRUS (RTV) ASSAY (October 3, 1997)
  • K964887 — VIDAS C. DIFFICILE TOXIN A II ASSAY (April 8, 1997)
  • K955627 — VIDAS CHLAMYDIA BLOCKING ASSAY (October 7, 1996)
  • K962609 — GRAM NEGATIVE IDENTIFICATION PLUS CARD (August 30, 1996)
  • K962549 — VIDAS CREATINE KINASE MB ASSAY 30-421 (August 30, 1996)
  • K952095 — VITEK GRAM POSITIVE IDENTIFICATION CARD (GPI) (March 12, 1996)
  • K955647 — VIDAS ESTRADIOL II (E2II) ASSAY (February 6, 1996)
  • K943812 — VIDAS LYME SCREEN II (June 13, 1995)
  • K942050 — HEMOLAB COFAC IX (May 19, 1995)

Other clearances for product code LIQ

  • K990842 — SAS ROTA TEST (August 9, 1999)
  • K972895 — VIDAS ROTAVIRUS (RTV) ASSAY (October 3, 1997)
  • K971585 — IMMUNOCARD STAT! ROTAVIRUS (August 20, 1997)
  • K964424 — ROTAVIRUS EIA (August 8, 1997)
  • K951208 — ROTA-DAN RAPID ROTAVIRUS EIA KIT (February 14, 1996)
  • K942286 — DIARLEX ROTA-ADENO (December 14, 1994)
  • K933587 — IMMUNOCARD ROTAVIRUS (February 3, 1994)
  • K932384 — IDEIA(TM) ROTAVIRUS (December 27, 1993)
  • K915137 — KALLESTAD ROTAVIRUS MICROPLATE (March 4, 1992)
  • K912666 — DAKO ELISA ROTAVIRUS KIT- 96 TESTS K440 (February 14, 1992)

FDA data resources