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510(k) K840901

PHASE II FREE T4 KIT by Medical & Scientific Designs, Inc. — Product Code CEC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 25, 1984
Date Received
February 28, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Free Thyroxine
Device Class
Class II
Regulation Number
862.1695
Review Panel
CH
Submission Type

Other clearances by Medical & Scientific Designs, Inc.

  • K862960 — PHASE II FERRITIN RADIOIMMUNOASSAY KIT (August 27, 1986)
  • K853224 — PHASE II B-12/FOLATE KIT (October 3, 1985)
  • K840328 — PHASE II HCG KIT (April 19, 1984)
  • K834219 — PHASE II CORTISOL KIT (February 4, 1984)
  • K833789 — PHASE II THEOPHYLLINE RADIOIMMUNOASSAY (January 24, 1984)
  • K832499 — PHASE II TSH KIT (September 12, 1983)
  • K832210 — GAMMA PHOTON GAMMA COUNTER (August 24, 1983)
  • K832209 — KINETI COUNT 24 GAMMA COUNTER (August 24, 1983)
  • K831064 — PHASE II T3 RADIOIMMUNOASSAY KIT (May 9, 1983)
  • K830900 — UPTAKE T3 RADIOIMMUNOASSAY KIT (April 18, 1983)

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