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510(k) K843710

ELISA FOR TOTAL IGE by Scientific Research — Product Code DGC

K843710 is an FDA 510(k) premarket notification submitted by Scientific Research for the device "ELISA FOR TOTAL IGE". The FDA issued a decision of Substantially Equivalent on October 22, 1984. The device falls under product code DGC (Ige, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5510. Scientific Research has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 22, 1984
Date Received
September 21, 1984
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 Scientific Research

  • K912420 — ORTHOFIX UNREAMED TIBIAL NAIL SYSTEM (September 23, 1991)
  • K843077 — ELISA FOR HERPES SIMPLEX VIRUS (June 21, 1985)
  • K842887 — HERPES VIRUS AGGLUTINATION TEST (February 26, 1985)
  • K843369 — AGGLUTINATION TEST FOR TOTAL IGE (November 14, 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