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510(k) K924218

BAC-T-SCREEN by Biomerieux Vitek, Inc. — Product Code JXA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 3, 1993
Date Received
August 20, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Kit, Screening, Urine
Device Class
Class I
Regulation Number
866.2660
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)
  • K965092 — VIDAS ROTAVIRUS ASSAY (May 5, 1997)
  • K964887 — VIDAS C. DIFFICILE TOXIN A II ASSAY (April 8, 1997)
  • K955627 — VIDAS CHLAMYDIA BLOCKING ASSAY (October 7, 1996)
  • K962549 — VIDAS CREATINE KINASE MB ASSAY 30-421 (August 30, 1996)
  • K962609 — GRAM NEGATIVE IDENTIFICATION PLUS CARD (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)

Other clearances for product code JXA

  • K011043 — OSMETECH MICROBIAL ANALYSER-URINARY TRACT INFECTION DETECTOR (OMA-UTI) (November 30, 2001)
  • K981084 — URISCREEN (October 7, 1998)
  • K972676 — URINE SCREENING DEVICE (February 23, 1998)
  • K952246 — TRI-TECHIN. CUSTOM BLOOD AND/OR URINE TRANSPORT KIT (June 20, 1995)
  • K950257 — MULTIPLE (IZON DBS & URINE COLLECTION KIT) (April 14, 1995)
  • K950246 — MULTIPLE (IZON URINE COLLECTION KIT) (March 21, 1995)
  • K950221 — MULTIPLE (IZON BLOOD & URINE COLLECTION KIT) (March 21, 1995)
  • K934759 — CULTURIA MACCONKEY-MUG (September 9, 1994)
  • K921045 — DIASLIDE URINE CULTURING DEVICE (September 28, 1992)
  • K911846 — URI-THREE(TM), MODIFICATION (October 4, 1991)