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510(k) K813216

SECURE FDI TEST KIT by Beckman Instruments, Inc. — Product Code JHG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 17, 1981
Date Received
November 9, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Chromatographic Separation, Lecithin/Sphingomyelin Ratio
Device Class
Class II
Regulation Number
862.1455
Review Panel
CH
Submission Type

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