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510(k) K790133

SPINSEP-FE59 by Nuclear Diagnostics, Inc. — Product Code JQG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 2, 1979
Date Received
January 23, 1979
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

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  • K932406 — NUCLITRYP(TM)(I125)-HUMAN PANCREA CATH TRY RAD KIT (December 2, 1993)
  • K872177 — TIPSEP-CORTISOL RIA DIAGNOSTIC KIT (June 17, 1987)
  • K862312 — ENZLIPASE, ENZYMATIC LIPASE KIT (September 26, 1986)
  • K860472 — NUCLEAR LASER ALIGNMENT SYSTEM FOR CARDIC STRESS (July 3, 1986)
  • K861735 — TIPSEP-TBG ASSAY (June 13, 1986)
  • K852291 — TIPSEP DIGOXIN RIA (June 25, 1985)
  • K833713 — SERUM THYROTROPIN ASSAY KIT, TIPSEP- (December 29, 1983)

Other clearances for product code JQG

  • K811954 — COMBO-FER IRON DIAGNOSTIC (July 27, 1981)
  • K800710 — FERRITIRON KIT CAT. #RP-1100 (May 14, 1980)
  • K800868 — FERRO-QUANT TM FE 59 TEST KIT (April 29, 1980)
  • K780412 — TOTAL IRON BINDING CAPACITY (May 26, 1978)