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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Colorimetry, Acetaminophen
510(k) Number K851278
Device Name ACETAZYME, STANBIO ACETAMINOPHEN PROC/TEST 0870
Applicant
Stanbio Laboratory
2930 E. Houston St.
San Antonio,  TX  78202
Applicant Contact HOWARD C LEIFHEIT
Correspondent
Stanbio Laboratory
2930 E. Houston St.
San Antonio,  TX  78202
Correspondent Contact HOWARD C LEIFHEIT
Regulation Number862.3030
Classification Product Code
LDP  
Date Received04/01/1985
Decision Date 04/17/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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