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510(k) K925915

VITEK RAPID CALL-GRAM NEGATIV IDENT CARD by Biomerieux Vitek, Inc. — Product Code LQM

K925915 is an FDA 510(k) premarket notification submitted by Biomerieux Vitek, Inc. for the device "VITEK RAPID CALL-GRAM NEGATIV IDENT CARD". The FDA issued a decision of Substantially Equivalent on March 23, 1993. The device falls under product code LQM (Gram Negative Identification Panel), a Class I device regulated under 21 CFR 866.2660. Biomerieux Vitek, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 23, 1993
Date Received
November 23, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Gram Negative Identification Panel
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)
  • 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)

Other clearances for product code LQM

  • K923313 — ROCHE OXI/FERM II (April 5, 1993)
  • K912897 — SCEPTOR IDENTIFICATION SYSTEM (October 28, 1991)
  • K911429 — VITEK GRAM NEGATIVE IDENTIFICATION CARD, MODIFIED (June 24, 1991)
  • K890057 — SENSITITRE AUTO ID PLATE AP80 (June 9, 1989)
  • K862642 — GRAM NEGATIVE FLUORESCENT IDENTIFICATION PANEL (September 11, 1986)
  • K851528 — PASCO GRAM NEGATIVE IDENTIFICATION SYSTEM (July 15, 1985)

FDA data resources