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510(k) K952095

VITEK GRAM POSITIVE IDENTIFICATION CARD (GPI) by Biomerieux Vitek, Inc. — Product Code LQL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 12, 1996
Date Received
May 4, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Gram Positive Identification Panel
Device Class
Class I
Regulation Number
866.2660
Review Panel
MI
Submission Type

Other clearances by Biomerieux Vitek, Inc.

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  • 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)
  • K955647 — VIDAS ESTRADIOL II (E2II) ASSAY (February 6, 1996)
  • K943812 — VIDAS LYME SCREEN II (June 13, 1995)
  • K942050 — HEMOLAB COFAC IX (May 19, 1995)

Other clearances for product code LQL

  • K972576 — GRAM POSITIVE AUTOIDENTIFICATION PLATES, SENSITITRE AP90 (January 22, 1998)
  • K961730 — RAPID GRAM-POSITIVE ID SYSTEM (February 4, 1997)
  • K961968 — BBLCRYSTAL GRAM-POSITIVE ID SYSTEM (February 4, 1997)
  • K925916 — VITEK RAPID CALL-GRAM POSITIVE IDENTIFICATION CARD (March 23, 1993)
  • K910304 — RAPID CORYNE SYST/IDENTIF OF CORYNEFORM BACTERIA (July 26, 1991)
  • K910537 — VISI-STREP (April 12, 1991)
  • K901559 — MODIFICATION TO API UNISCEPT 20GP (September 10, 1990)
  • K891004 — RAPIDEC STAPH (November 9, 1989)
  • K874606 — CATHRA GRAM POSITIVE SCREEN (May 6, 1988)
  • K863038 — GRAM POSITIVE FLUORESCENT IDENTIFICATION PANEL (September 30, 1986)