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510(k) K972697

AIA-PACK IGE II ASSAY by Tosoh Medics, Inc. — Product Code DGC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 3, 1997
Date Received
July 18, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ige, Antigen, Antiserum, Control
Device Class
Class II
Regulation Number
866.5510
Review Panel
IM
Submission Type

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  • K023891 — ST AIA-PACK CA 125 ENZYME IMMUNOASSAY (December 6, 2002)
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  • K012820 — AIA-PACK CTNI 2ND-GEN ASSAY (December 14, 2001)
  • K011434 — G7 AUTOMATED HPLC ANALYZER (September 18, 2001)
  • 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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