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510(k) K863006

125-I TSH RECEPTOR ANTIBODY KIT by Cronus — Product Code JZO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 8, 1986
Date Received
August 8, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Test, Thyroid Autoantibody
Device Class
Class II
Regulation Number
866.5870
Review Panel
IM
Submission Type

Other clearances by Cronus

  • K871193 — I-125 ANTI-THYROGLOBULIN ANTIBODY IRMA TEST KIT (May 15, 1987)
  • K871194 — I-125 ANTI-MICROSOMAL ANTIBODY IRMA TEST KIT (April 20, 1987)

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