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510(k) K922768

RAPID NFT, MODIFICATION by Biomerieux Vitek, Inc. — Product Code JSW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 14, 1992
Date Received
June 8, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Kit, Identification, Glucose Nonfermenter
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 JSW

  • K900517 — RAPID NF SYSTEM (March 13, 1990)
  • K870769 — AUSTIN NONFERMENTER KIT (April 3, 1987)
  • K790992 — PSEUDO-PALETTE TM (June 22, 1979)
  • K772112 — NON-FERMENTER SYSTEM (November 17, 1977)
  • K770745 — PANEL, GNF, MICRO-ID (June 23, 1977)