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510(k) K792539

TRIIODOTHYRONINE RIA SYSTEM by Radioimmunoassay, Inc. — Product Code CDP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 16, 1980
Date Received
December 10, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Total Triiodothyronine
Device Class
Class II
Regulation Number
862.1710
Review Panel
CH
Submission Type

Other clearances by Radioimmunoassay, Inc.

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  • K800106 — LUTEINIZING HORMONE RADIOIMMUNOASSAY SYS (February 13, 1980)
  • K800107 — FOLLICLE STIMULATING HORMONE (February 13, 1980)
  • K792154 — THYROID STIMULATING HORMONE (November 13, 1979)
  • K792153 — DIGOXIN RADIOIMMUNOASSAY SYSTEM (November 13, 1979)
  • K792036 — CORTISOL RADIOIMMUNOASSAY SYSTEM (October 30, 1979)
  • K780672 — 125 I-T4 RIA REAGENT (June 6, 1978)
  • K780671 — 125 I-T3 UPTAKE REAGENT (June 6, 1978)

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