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510(k) K925915

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

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

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  • 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 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)