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510(k) K871194

I-125 ANTI-MICROSOMAL ANTIBODY IRMA TEST KIT by Cronus — Product Code DBL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 20, 1987
Date Received
March 24, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control
Device Class
Class II
Regulation Number
866.5660
Review Panel
IM
Submission Type

Other clearances by Cronus

  • K871193 — I-125 ANTI-THYROGLOBULIN ANTIBODY IRMA TEST KIT (May 15, 1987)
  • K863006 — 125-I TSH RECEPTOR ANTIBODY KIT (September 8, 1986)

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