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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Fluorescent Immunoassay, Theophylline
510(k) Number K823576
Device Name COBAS STANDARD FOR TOTAL PROTEIN
Applicant
Hoffmann-La Roche, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Hoffmann-La Roche, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number862.3880
Classification Product Code
LER  
Date Received12/06/1982
Decision Date 01/07/1983
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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