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510(k) K931224

VIDAS TOTAL IGE (IGE) ASSAY by Biomerieux Vitek, Inc. — Product Code DGP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 20, 1993
Date Received
March 10, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ige, Fitc, Antigen, Antiserum, Control
Device Class
Class II
Regulation Number
866.5510
Review Panel
IM
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)
  • 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 DGP

  • K863327 — IMMPULSE IGE ASSAY REAGENTS (December 3, 1986)
  • K842749 — FIAX TOTAL IGE TEST KIT (August 28, 1984)
  • K842969 — ALLERGENETICS ALLER-SPECIFIC IGE SERUM (August 28, 1984)