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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bromcresol Green Dye-Binding, Albumin
510(k) Number K952488
Device Name TRACE COBAS MIRA RANGE
Applicant
Trace Scientific , Ltd.
7260 NW 58th St.
Miami,  FL  33166
Applicant Contact David Johnston
Correspondent
Trace Scientific , Ltd.
7260 NW 58th St.
Miami,  FL  33166
Correspondent Contact David Johnston
Regulation Number862.1035
Classification Product Code
CIX  
Subsequent Product Codes
CDQ   CEK   CEO   CFJ   CFR  
CGX   CHJ   CIG   CIT   CJE   CKA  
JFJ   JGJ   JGY   JLP   JQB   KHS  
KNK  
Date Received05/30/1995
Decision Date 10/13/1995
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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