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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Turbidimetric, Total Protein
510(k) Number K780110
Device Name CSF TOTAL PROTEIN TEST SET #0340
Applicant
Stanbio Laboratory
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Stanbio Laboratory
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number862.1635
Classification Product Code
JGQ  
Date Received01/19/1978
Decision Date 03/03/1978
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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