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510(k) K831569

REAGENT CUPS by American Scientific Products — Product Code JJG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 30, 1983
Date Received
May 16, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Analyzer, Chemistry, Centrifugal, For Clinical Use
Device Class
Class I
Regulation Number
862.2140
Review Panel
CH
Submission Type

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  • K822799 — STREPTACOCCUS CO-AGGLUTINATION KIT (December 19, 1982)

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