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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calibrator, Secondary
510(k) Number K020454
Device Name CHEMISTRY CALIBRATOR
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 Number862.1150
Classification Product Code
JIT  
Date Received02/11/2002
Decision Date 04/08/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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