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510(k) K972586

AIA-PACK TSH 3RD-GEN ASSAY by Tosoh Medics, Inc. — Product Code JLW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 29, 1997
Date Received
July 11, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Thyroid-Stimulating Hormone
Device Class
Class II
Regulation Number
862.1690
Review Panel
CH
Submission Type

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  • K010796 — AIA-PACK BRCA, ST AIA PACK BRCA (August 16, 2001)
  • K992365 — AIA-PACK FOLATE ASSAY (August 10, 1999)
  • K990431 — AIA-PACK CA 125 (June 3, 1999)

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