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510(k) K962609

GRAM NEGATIVE IDENTIFICATION PLUS CARD by Biomerieux Vitek, Inc. — Product Code LRH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 30, 1996
Date Received
July 3, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument For Auto Reader Of Overnight Microorganism Identification System
Device Class
Class I
Regulation Number
866.2660
Review Panel
MI
Submission Type

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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)
  • 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)
  • K942050 — HEMOLAB COFAC IX (May 19, 1995)

Other clearances for product code LRH

  • K961042 — MICROSCAN RAPID GRAM-NEGATIVE INDENTIFICATION TYPE 3 PANEL (May 30, 1996)
  • K926248 — READER (May 17, 1994)
  • K920225 — AUTOSCEPTOR IDENTIFICATION SYSTEM (May 22, 1992)