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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Multi-Analyte Controls, All Kinds (Assayed)
510(k) Number K881438
Device Name UREA/GLUCOSE/CREATININE SERUM RANGE LINEARITY STAN
Applicant
HICHEM DIAGNOSTICS
231 N. PUENTE ST.
BREA,  CA  92621
Applicant Contact WYNN STOCKING
Correspondent
HICHEM DIAGNOSTICS
231 N. PUENTE ST.
BREA,  CA  92621
Correspondent Contact WYNN STOCKING
Regulation Number862.1660
Classification Product Code
JJY  
Date Received04/05/1988
Decision Date 07/06/1988
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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