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510(k) K832499

PHASE II TSH KIT by Medical & Scientific Designs, Inc. — Product Code JLW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 12, 1983
Date Received
July 27, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Thyroid-Stimulating Hormone
Device Class
Class II
Regulation Number
862.1690
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)
  • 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)
  • 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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