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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Azo Dye, Calcium
510(k) Number K011441
Device Name JAS CALCIUM (ARSENAZO) REAGENT
Applicant
JAS Diagnostics, Inc.
7220 NW 58TH ST.
MIAMI,  FL  33166
Applicant Contact David Johnston
Correspondent
JAS Diagnostics, Inc.
7220 NW 58TH ST.
MIAMI,  FL  33166
Correspondent Contact David Johnston
Regulation Number862.1145
Classification Product Code
CJY  
Date Received05/10/2001
Decision Date 07/09/2001
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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