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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Nitroprusside Reaction (Qualitative, Urine), Cystine
510(k) Number K843382
Device Name UROCYSTIN
Applicant
Mission Pharmacal Co.
P.O. Box 1676
San Antonio,  TX  78296
Applicant Contact GEORGE ALEXANDRIDES
Correspondent
Mission Pharmacal Co.
P.O. Box 1676
San Antonio,  TX  78296
Correspondent Contact GEORGE ALEXANDRIDES
Regulation Number862.1240
Classification Product Code
JLC  
Date Received08/28/1984
Decision Date 01/08/1985
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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