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510(k) K822341

ALLERGENETICS IGE-FAST TEST by Allergenetics — Product Code DGC

K822341 is an FDA 510(k) premarket notification submitted by Allergenetics for the device "ALLERGENETICS IGE-FAST TEST". The FDA issued a decision of Substantially Equivalent on November 10, 1982. The device falls under product code DGC (Ige, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5510. Allergenetics has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 10, 1982
Date Received
August 4, 1982
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 Allergenetics

  • K851512 — ALLERGENETICS IGE FAST TEST (May 28, 1985)
  • K842970 — ALLERGENTICS TOTAL IGE/THEOPHYLLINE (August 29, 1984)
  • K842969 — ALLERGENETICS ALLER-SPECIFIC IGE SERUM (August 28, 1984)
  • K833418 — CHYMOFAST TEST (March 12, 1984)
  • K834594 — TOTAL IGE FAST TEST (February 10, 1984)
  • K833419 — LABELED 125I ANTI-IGE (February 3, 1984)
  • K834244 — THEOFAST TEST KIT FOR QUANTITATIVE THEO (January 24, 1984)

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