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510(k) K811954

COMBO-FER IRON DIAGNOSTIC by Immuno Assay Corp. — Product Code JQG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 27, 1981
Date Received
July 8, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radiometric, Fe59, Iron Binding Capacity
Device Class
Class I
Regulation Number
862.1415
Review Panel
CH
Submission Type

Other clearances by Immuno Assay Corp.

  • K833842 — RIA COAT DIGOXIN (January 17, 1984)
  • K833745 — RIACOAT T-4 (January 4, 1984)
  • K820089 — TSH (RIA) KIT (January 28, 1982)
  • K820074 — CORTISOL (RIA) KIT (January 28, 1982)
  • K811725 — TBG DIAGNOSTIC KIT (July 10, 1981)
  • K811213 — T3 (RIA) KIT (May 29, 1981)
  • K811212 — DIGOXIN (RIA) KIT (May 21, 1981)
  • K810857 — T3 UPTAKE KIT (April 8, 1981)
  • K810811 — T4 RIA KIT (April 7, 1981)

Other clearances for product code JQG

  • K800710 — FERRITIRON KIT CAT. #RP-1100 (May 14, 1980)
  • K800868 — FERRO-QUANT TM FE 59 TEST KIT (April 29, 1980)
  • K790133 — SPINSEP-FE59 (March 2, 1979)
  • K780412 — TOTAL IRON BINDING CAPACITY (May 26, 1978)