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510(k) K833418

CHYMOFAST TEST by Allergenetics — Product Code DHB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 12, 1984
Date Received
October 3, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Test, Radioallergosorbent (Rast) Immunological
Device Class
Class II
Regulation Number
866.5750
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)
  • 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)

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