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510(k) K062516

ACCESS THYROGLOBULIN ANTIBODY II ASSAY, MODELS A32898 (REAGENT) AND A36920 (CALIBRATORS) by Beckman Coulter, Inc. — Product Code JNL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 5, 2006
Date Received
August 28, 2006
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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Other clearances for product code JNL

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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)
  • K951362 — THYROGLOBULIN EIA TEST KIT (November 20, 1995)
  • K951364 — MICROSOMAL EIA TEST KIT (November 20, 1995)