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510(k) K830900

UPTAKE T3 RADIOIMMUNOASSAY KIT by Medical & Scientific Designs, Inc. — Product Code KHQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 18, 1983
Date Received
March 21, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioassay, Triiodothyronine Uptake
Device Class
Class II
Regulation Number
862.1715
Review Panel
CH
Submission Type

Other clearances by Medical & Scientific Designs, Inc.

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  • K840901 — PHASE II FREE T4 KIT (April 25, 1984)
  • 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)

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  • K934312 — AXSYM(TM) T-UPTAKE (June 21, 1994)
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