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510(k) K894200

FREE T3 RADIOIMMUNOASSAY KIT by Advanced Magnetics, Inc. — Product Code CDP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 25, 1989
Date Received
June 16, 1989
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 Advanced Magnetics, Inc.

  • K902748 — SEROZYME FREE T3 IMMUNOASSAY (August 9, 1990)
  • K900060 — FREE T4 IMMUNOASSAY KIT (March 29, 1990)
  • K884753 — MODIFIED FREE T4 RADIOIMMUNOASSAY KIT (February 27, 1989)

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