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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Colorimetry, Cholinesterase
510(k) Number K914171
Device Name IN VITRO DIAGNOSTIC REGEANT SET,CHOLINESTERASE
Applicant
Tech Intl. Co.
1856 Starr-Batt Dr.
Rochester Hills,  MI  48309
Correspondent
Tech Intl. Co.
1856 Starr-Batt Dr.
Rochester Hills,  MI  48309
Regulation Number862.3240
Classification Product Code
DIH  
Date Received09/17/1991
Decision Date 12/18/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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