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510(k) K834244

THEOFAST TEST KIT FOR QUANTITATIVE THEO by Allergenetics — Product Code KLS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 24, 1984
Date Received
December 7, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Immunoassay, Theophylline
Device Class
Class II
Regulation Number
862.3880
Review Panel
TX
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)
  • K822341 — ALLERGENETICS IGE-FAST TEST (November 10, 1982)

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  • K973583 — ACE THEOPHYLLINE REAGENT, THEO CALIBRATORS (November 12, 1997)
  • K972495 — ACCUMETER THEOPHYLLINE TEST (October 10, 1997)
  • K961462 — CEDIA THEOPHYLLINE ASSAY (June 27, 1996)