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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Drug Specific Control Materials
510(k) Number K811619
Device Name EMIT-ST SERUM PHENOBARBITAL CONTROLS
Applicant
Syva Co.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Syva Co.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number862.3280
Classification Product Code
LAS  
Date Received06/08/1981
Decision Date 06/25/1981
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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