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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name colorimetric method, lipoproteins
510(k) Number K022519
Device Name LDL CHOLESTEROL (AUTOMATED)
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 Number862.1475
Classification Product Code
JHM  
Subsequent Product Codes
JIX   JJY   MRR  
Date Received07/30/2002
Decision Date 09/30/2002
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
Recalls CDRH Recalls
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