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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enzyme Immunoassay, Lidocaine
510(k) Number K822347
Device Name LIDOCAINE FLUORESCENT IMMUNOASSAY
Applicant
American Diagnostic Corp.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
American Diagnostic Corp.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number862.3555
Classification Product Code
KLR  
Date Received08/06/1982
Decision Date 08/25/1982
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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