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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Drug Mixture Control Materials
510(k) Number K812950
Device Name QAC CONTROL
Applicant
The Quality Assurance Service Corp.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
The Quality Assurance Service Corp.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number862.3280
Classification Product Code
DIF  
Date Received10/21/1981
Decision Date 12/17/1981
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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