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510(k) K771993

AFT SYSTEM by Calbiochem — Product Code DBM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 2, 1977
Date Received
October 21, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control
Device Class
Class II
Regulation Number
866.5090
Review Panel
IM
Submission Type

Other clearances by Calbiochem

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  • K760366 — REAGENT, Y-GT MAX-PACK (November 1, 1976)

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