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510(k) K913493

AIA-PACK FT4 by Tosoh Corp. — Product Code CEC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 10, 1991
Date Received
August 6, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Free Thyroxine
Device Class
Class II
Regulation Number
862.1695
Review Panel
CH
Submission Type

Other clearances by Tosoh Corp.

  • K023240 — ST AIA-PACK CA 19-9 (December 23, 2002)
  • K023239 — AIA-PACK CA 19-9 (December 23, 2002)
  • K923021 — AIA-1200DX - AUTOMATED ENZYME IMMUNOASSAY SYSTEM (July 21, 1992)
  • K913663 — AIA-PACK T-U (September 30, 1991)
  • K913298 — AIA-PACK CK-MB (September 27, 1991)
  • K903628 — AIA-PACK IRI (September 7, 1990)
  • K901965 — MPR-4A - MICRO-PLATE READER (May 10, 1990)
  • K901674 — AIA-600 AUTOMATED ENZYME IMMUNOASSAY SYSTEM (May 2, 1990)
  • K897001 — TOSOH AIA-PACK T3 (March 9, 1990)
  • K896982 — AIA-PACK T4 (March 9, 1990)

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  • K140859 — DIMENSION VISTA FREE THYROXINE FLEX REAGENT CARTRIDGE, FT4, DIMENSION VISTA THYR (November 26, 2014)
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