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510(k) K912371

BIOMERIEUX RSV DIRECT IF KIT by Vitek Systems, Inc. — Product Code LKT

K912371 is an FDA 510(k) premarket notification submitted by Vitek Systems, Inc. for the device "BIOMERIEUX RSV DIRECT IF KIT". The FDA issued a decision of Substantially Equivalent on September 23, 1991. The device falls under product code LKT (Respiratory Syncytial Virus, Antigen, Antibody, Ifa), a Class I device regulated under 21 CFR 866.3480. Vitek Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 23, 1991
Date Received
May 29, 1991
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 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)
  • 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)
  • K911429 — VITEK GRAM NEGATIVE IDENTIFICATION CARD, MODIFIED (June 24, 1991)

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)
  • K894623 — RESPIRATORY SYNCYTIAL VIRUS (October 16, 1989)
  • 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