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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calibrators, Drug Mixture
510(k) Number K820461
Device Name EMIT-ST URINE CALIBRATOR A (#3A319
Applicant
Syva Co.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Syva Co.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number862.3200
Classification Product Code
DKB  
Date Received02/19/1982
Decision Date 03/11/1982
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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