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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name biuret (colorimetric), total protein
510(k) Number K961864
Device Name CSF/URINE TOTAL PROTEIN
Applicant
TECO DIAGNOSTICS
911 VIA RODEO
PLACENTIA,  CA  92670
Applicant Contact K.C. CHEN, PH.D.
Correspondent
TECO DIAGNOSTICS
911 VIA RODEO
PLACENTIA,  CA  92670
Correspondent Contact K.C. CHEN, PH.D.
Regulation Number862.1635
Classification Product Code
CEK  
Date Received05/14/1996
Decision Date 10/24/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
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