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510(k) K992365

AIA-PACK FOLATE ASSAY by Tosoh Medics, Inc. — Product Code CGN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 10, 1999
Date Received
July 15, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Acid, Folic, Radioimmunoassay
Device Class
Class II
Regulation Number
862.1295
Review Panel
CH
Submission Type

Other clearances by Tosoh Medics, Inc.

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  • K023891 — ST AIA-PACK CA 125 ENZYME IMMUNOASSAY (December 6, 2002)
  • K020489 — G7 AUTOMATED HPLC ANALYZER, BETA-THALASSEMIA MODE (May 14, 2002)
  • 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)
  • K990431 — AIA-PACK CA 125 (June 3, 1999)
  • K991252 — AIA-PACK FT3 ASSAY (May 11, 1999)

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