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510(k) K962762

SEQUENTIAL SAMPLE MULTI-PHOTON DETECTOR by Biotraces, Inc. — Product Code JJJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 16, 1996
Date Received
July 16, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Counter (Beta, Gamma) For Clinical Use
Device Class
Class I
Regulation Number
862.2320
Review Panel
CH
Submission Type

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