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510(k) K842969

ALLERGENETICS ALLER-SPECIFIC IGE SERUM by Allergenetics — Product Code DGP

K842969 is an FDA 510(k) premarket notification submitted by Allergenetics for the device "ALLERGENETICS ALLER-SPECIFIC IGE SERUM". The FDA issued a decision of Substantially Equivalent on August 28, 1984. The device falls under product code DGP (Ige, Fitc, 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
August 28, 1984
Date Received
July 30, 1984
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 Allergenetics

  • K851512 — ALLERGENETICS IGE FAST TEST (May 28, 1985)
  • K842970 — ALLERGENTICS TOTAL IGE/THEOPHYLLINE (August 29, 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)
  • K822341 — ALLERGENETICS IGE-FAST TEST (November 10, 1982)

Other clearances for product code DGP

  • K931224 — VIDAS TOTAL IGE (IGE) ASSAY (May 20, 1993)
  • K863327 — IMMPULSE IGE ASSAY REAGENTS (December 3, 1986)
  • K842749 — FIAX TOTAL IGE TEST KIT (August 28, 1984)

FDA data resources