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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catalytic Methods, Amylase
510(k) Number K870746
Device Name STANBIO ALPHA-AMYLASE TEST SET, CATALOG 0180-715
Applicant
Stanbio Laboratory
2930 E. Houston St.
San Antonio,  TX  78202
Applicant Contact W. R PIPPIN
Correspondent
Stanbio Laboratory
2930 E. Houston St.
San Antonio,  TX  78202
Correspondent Contact W. R PIPPIN
Regulation Number862.1070
Classification Product Code
JFJ  
Date Received02/25/1987
Decision Date 06/01/1987
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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