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510(k) K782159

DIAGNOSTIC KIT, FERRITAB-FE-59 by Leeco Diagnostics, Inc. — Product Code JJA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 1, 1979
Date Received
December 22, 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 Leeco Diagnostics, Inc.

  • K895765 — LEECO PREVIEW(R) EBV (EIA) (October 31, 1989)
  • K894122 — LEECO VIS-DISK STREP-A (EIA) (August 15, 1989)
  • K891096 — VIS-DISK HCG (EIA) JPL-041M (June 16, 1989)
  • K891095 — VIS-DISK HCG (EIA) LYOPHILIZED JPL-044M (June 16, 1989)
  • K883269 — PRL-QUANT (September 13, 1988)
  • K880577 — CONCEP-7-BHCG (March 15, 1988)
  • K880069 — LEECO PREGNASTICK (EIA) CATALOG #003 (February 11, 1988)
  • K870259 — VIS-CUBE HCG (EIA) LYOPHILIZED JPL-044 (March 10, 1987)
  • K864170 — LEECO VIS-CUBE STREP A (EIA) (February 3, 1987)
  • K863999 — VIS-CUBE PREGNANCY HOME TEST,CAT. # JPL-042 (January 9, 1987)

Other clearances for product code JJA

  • K820253 — SIMUL-FER SERUM IRON TEST KIT (May 12, 1982)
  • K781769 — IRON 59 KIT (December 4, 1978)
  • K760045 — KIT, RADIOASSAY, SERUM IRON (July 20, 1976)