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510(k) K931224

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

K931224 is an FDA 510(k) premarket notification submitted by Biomerieux Vitek, Inc. for the device "VIDAS TOTAL IGE (IGE) ASSAY". The FDA issued a decision of Substantially Equivalent on May 20, 1993. The device falls under product code DGP (Ige, Fitc, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5510. Biomerieux Vitek, Inc. has at least 10 other 510(k) clearances on record.

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)
  • K962609 — GRAM NEGATIVE IDENTIFICATION PLUS CARD (August 30, 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)

Other clearances for product code DGP

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

FDA data resources