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510(k) K032251

IMMUNETECH TOTAL IGE SYSTEM by Immunetech Corporation — Product Code DGC

K032251 is an FDA 510(k) premarket notification submitted by Immunetech Corporation for the device "IMMUNETECH TOTAL IGE SYSTEM". The FDA issued a decision of Substantially Equivalent on December 19, 2003. The device falls under product code DGC (Ige, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5510. Immunetech Corporation has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 19, 2003
Date Received
July 22, 2003
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 Immunetech Corporation

  • K061979 — MODIFICATION TO MYALLERGY TEST (September 22, 2006)
  • K021698 — MY ALLERGY TEST (September 19, 2002)
  • K020387 — MYALLERGYTEST SYSTEM (April 17, 2002)

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)
  • K050493 — QUANTIA IGE (August 16, 2005)
  • K042241 — K-ASSAY TOTAL IGE, K-ASSAY IGE CALIBRATOR SET, MODELS KAI-092/KAI-093C (December 10, 2004)
  • K034057 — LACRYTEST (March 9, 2004)

FDA data resources