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510(k) K792231

AMS YEAST BIOCHEMICAL CARD by Vitek Systems, Inc. — Product Code JXB

K792231 is an FDA 510(k) premarket notification submitted by Vitek Systems, Inc. for the device "AMS YEAST BIOCHEMICAL CARD". The FDA issued a decision of Substantially Equivalent on December 19, 1979. The device falls under product code JXB (Kit, Identification, Yeast), a Class I device regulated under 21 CFR 866.2660. Vitek Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 19, 1979
Date Received
November 5, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Kit, Identification, Yeast
Device Class
Class I
Regulation Number
866.2660
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 JXB

  • K080719 — YEAST TRAFFIC LIGHT PNA FISH (September 12, 2008)
  • K062461 — C. ALBICANS PNA FISH (October 25, 2006)
  • K993554 — YEASTEST (February 10, 2000)
  • K943621 — RAPID YEAST PLUS SYSTEM (January 27, 1995)
  • K935124 — BACTICARD CANDIDA (February 25, 1994)
  • K900112 — MICRORING YT (July 31, 1990)
  • K881925 — VITEK YEAST BIOCHEMICAL CARD (June 16, 1988)
  • K860575 — YEAST IDENTIFICATION PANEL (May 13, 1986)
  • K830286 — YEAST IDENT (April 5, 1983)
  • K802309 — MS-2 IDENTIFICATION SYSTEM (December 1, 1980)

FDA data resources