Home / 510(k) Clearances / K050493

510(k) K050493

QUANTIA IGE by Biokit, S.A. — Product Code DGC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 16, 2005
Date Received
February 28, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ige, Antigen, Antiserum, Control
Device Class
Class II
Regulation Number
866.5510
Review Panel
IM
Submission Type

Other clearances by Biokit, S.A.

  • K243575 — ARCHITECT HSV-2 IgG, ARCHITECT HSV-2 IgG Calibrator, ARCHITECT HSV-2 IgG Control (February 12, 2025)
  • K233606 — ADVIA Centaur EBV-VCA IgM (August 7, 2024)
  • K233605 — ADVIA Centaur EBV-EBNA IgG (August 7, 2024)
  • K213987 — ARCHITECT HSV-1 IgG, ARCHITECT HSV-1 IgG Calibrator, ARCHITECT HSV-1 IgG Control (September 20, 2023)
  • K214068 — Quantia IgE (February 21, 2023)
  • K181334 — ADVIA Centaur Herpes-2 IgG (August 23, 2018)
  • K181333 — ADVIA Centaur Herpes-1 IgG (August 23, 2018)
  • K152185 — ARCHITECT SHBG (February 11, 2016)
  • K132400 — LP(A) CALIBRATORS, AND LP(A) CONTROLS (December 19, 2013)
  • K123947 — ARCHITECT IVANCOMYCIN (August 29, 2013)

Other clearances for product code DGC

  • K231151 — Kenota 1 Total IgE; Kenota 1 (instrument) (May 31, 2024)
  • K214068 — Quantia IgE (February 21, 2023)
  • K220178 — Total Immunoglobulin E (IgE) (March 23, 2022)
  • K193493 — ADVIA Centaur Total IgE (tIgE) (January 15, 2020)
  • K161899 — ImmunoCAP Total IgE Calibrator Strip/Total IgE Curve Control Strip, ImmunoCAP To (July 28, 2016)
  • K133404 — IMMUNOCAP TOTAL IGE: CONJUGATE, ANTI-IGE, CALIBRATORS, CURVE CONTROLS, CONTROL L (February 24, 2014)
  • K063425 — DIMENSION VISTA IGE FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, PROTEIN 1 CONT (February 15, 2007)
  • K042241 — K-ASSAY TOTAL IGE, K-ASSAY IGE CALIBRATOR SET, MODELS KAI-092/KAI-093C (December 10, 2004)
  • K034057 — LACRYTEST (March 9, 2004)
  • K032251 — IMMUNETECH TOTAL IGE SYSTEM (December 19, 2003)