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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, Phenobarbital
510(k) Number K841707
Device Name INNOFLUOR PHENOBARBITAL
Applicant
Innotron Diagnostics
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Innotron Diagnostics
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number862.3660
Classification Product Code
LGQ  
Date Received04/23/1984
Decision Date 05/23/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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