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510(k) K112933

ACCESS THYROGLOBULIN ANITBODY by Beckman Coulter, Inc. — Product Code JNL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 27, 2011
Date Received
October 3, 2011
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Immunochemical, Thyroglobulin Autoantibody
Device Class
Class II
Regulation Number
866.5870
Review Panel
IM
Submission Type

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  • K971834 — ANTI-THYROID PEROXIDASE (TPO) MICROPLATE ELISA (July 3, 1997)
  • K962341 — HY-TEC/MANUAL AUTOIMMUNE KIT FOR THYROGLOBULIN (TG) (November 25, 1996)
  • K962451 — HY-TEC/MANUAL AUTOIMMUNE KIT FOR THYROID MICROSOMAL (TPO) (November 25, 1996)
  • K954256 — ANTI-TPO (November 27, 1995)
  • K951364 — MICROSOMAL EIA TEST KIT (November 20, 1995)
  • K951362 — THYROGLOBULIN EIA TEST KIT (November 20, 1995)