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510(k) K781769

IRON 59 KIT by Ria Products, Inc. — Product Code JJA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 4, 1978
Date Received
October 16, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radio-Labeled Iron Method, Iron (Non-Heme)
Device Class
Class I
Regulation Number
862.1410
Review Panel
CH
Submission Type

Other clearances by Ria Products, Inc.

  • K813310 — NO-HOIL COMBOSTAT II KIT (December 17, 1981)
  • K802969 — CORTISOL 125-I RADIOIMMUNOASSAY KIT (January 2, 1981)
  • K801579 — VITAMIN B12 - NO-BOIL KIT (October 23, 1980)
  • K801578 — COMBOSTAT - NO-BOIL KIT (October 23, 1980)
  • K800710 — FERRITIRON KIT CAT. #RP-1100 (May 14, 1980)
  • K800914 — NO-BOIL FOLATE KIT #RP-500 (May 8, 1980)
  • K781844 — FERRITIN KIT (January 10, 1979)
  • K780148 — RIA FOR FOLATES & VIT. B12, COMBO KIT (March 3, 1978)

Other clearances for product code JJA

  • K820253 — SIMUL-FER SERUM IRON TEST KIT (May 12, 1982)
  • K782159 — DIAGNOSTIC KIT, FERRITAB-FE-59 (February 1, 1979)
  • K760045 — KIT, RADIOASSAY, SERUM IRON (July 20, 1976)