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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Counter (Beta, Gamma) For Clinical Use
510(k) Number K962762
Device Name SEQUENTIAL SAMPLE MULTI-PHOTON DETECTOR
Applicant
Biotraces, Inc.
10517-A W. Dr.
Fairfax,  VA  22030
Applicant Contact JAMES E WADIAK
Correspondent
Biotraces, Inc.
10517-A W. Dr.
Fairfax,  VA  22030
Correspondent Contact JAMES E WADIAK
Regulation Number862.2320
Classification Product Code
JJJ  
Date Received07/16/1996
Decision Date 08/16/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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