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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Fluorescence Polarization Immunoassay, Diphenylhydantoin (Free)
510(k) Number K952555
Device Name COBAS-FP APPLICATION FOR FREE PHENYTOIN, COBAS-FP PHENYTOIN CALIBRATORS, & CONTROLS
Applicant
Roche Diagnostic Systems, Inc.
Branchburg Township
1080 U.S. Hwy. 202
Somerville,  NJ  08876
Applicant Contact RITA SMITH
Correspondent
Roche Diagnostic Systems, Inc.
Branchburg Township
1080 U.S. Hwy. 202
Somerville,  NJ  08876
Correspondent Contact RITA SMITH
Regulation Number862.3350
Classification Product Code
MOJ  
Date Received06/02/1995
Decision Date 07/31/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
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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