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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calibrator, Multi-Analyte Mixture
510(k) Number K844344
Device Name GEMCAL ENI REFERENCE SERUM
Applicant
Biocell Laboratories, Inc.
1117 E. Janis St.
Carson,  CA  90746
Applicant Contact FALKOWSKI
Correspondent
Biocell Laboratories, Inc.
1117 E. Janis St.
Carson,  CA  90746
Correspondent Contact FALKOWSKI
Regulation Number862.1150
Classification Product Code
JIX  
Date Received11/09/1984
Decision Date 01/03/1985
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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