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510(k) K830642

PHASE THYROXINE RADIOIMMUNOASSAY KIT by Medical & Scientific Designs, Inc. — Product Code CDX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 5, 1983
Date Received
March 1, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Total Thyroxine
Device Class
Class II
Regulation Number
862.1700
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)
  • K832209 — KINETI COUNT 24 GAMMA COUNTER (August 24, 1983)
  • K832210 — GAMMA PHOTON GAMMA COUNTER (August 24, 1983)
  • K831064 — PHASE II T3 RADIOIMMUNOASSAY KIT (May 9, 1983)

Other clearances for product code CDX

  • K961490 — ELECSYS T4 ASSAY (June 13, 1996)
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  • K943416 — DELFIA NEONATAL THYROXINE KIT (March 10, 1995)
  • K934384 — AXSYM(TM) TOTAL T4 (June 21, 1994)
  • K932980 — TOTAL T4 FPIA REAGENT SET/CALIBRATOR #T-1039,T-116 (October 18, 1993)
  • K933426 — STRATUS(R) TOTAL THYROXINE(T4) FLUOR ENZYME IMMUNO (August 26, 1993)
  • K931295 — IQ TT4 ASSAY (July 20, 1993)
  • K926563 — AUTOBEAD(TM) T4 ENZYME IMMUNOASSAY TEST KIT (March 18, 1993)
  • K925110 — ABBOTT IMX T4 (January 26, 1993)
  • K925109 — ABBOTT TDX/TDXFLX TT4 (January 4, 1993)