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510(k) K895805

SLIDEX ROTA-KIT 2 by Vitek Systems, Inc. — Product Code LIQ

K895805 is an FDA 510(k) premarket notification submitted by Vitek Systems, Inc. for the device "SLIDEX ROTA-KIT 2". The FDA issued a decision of Substantially Equivalent on February 26, 1991. The device falls under product code LIQ (Enzyme Linked Immunoabsorbent Assay, Rotavirus), a Class I device regulated under 21 CFR 866.3405. Vitek Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 26, 1991
Date Received
September 28, 1989
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 Vitek Systems, Inc.

  • K920661 — VIDAS CMV IGG ASSAY (February 12, 1993)
  • K921302 — VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM (July 28, 1992)
  • K921176 — VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM (April 8, 1992)
  • K920952 — VITEK IMMUNODIAG ASSAY SYST(VIDAS) FERRITINE ASSAY (April 7, 1992)
  • K915884 — VIDAS CHLAMYDIA ASSAY, MODIFICATION (March 4, 1992)
  • K905211 — VIDAS CLOSTRIDIUM DIFFICILE TOXIN A (CDA) ASSAY (October 11, 1991)
  • K912371 — BIOMERIEUX RSV DIRECT IF KIT (September 23, 1991)
  • K910230 — LYME-SPOT IF KIT (August 30, 1991)
  • K910210 — SLIDEX MENINGITE-KIT 5 (August 12, 1991)
  • K910304 — RAPID CORYNE SYST/IDENTIF OF CORYNEFORM BACTERIA (July 26, 1991)

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)
  • K965092 — VIDAS ROTAVIRUS ASSAY (May 5, 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)

FDA data resources