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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Multi-Analyte Controls, All Kinds (Assayed)
510(k) Number K936245
Device Name MULTI ANALYTE LINEARITY SET
Applicant
Teco Diagnostics
911 Via Rodeo
Placentia,  CA  92670
Applicant Contact K.C. CHEN, PH D.
Correspondent
Teco Diagnostics
911 Via Rodeo
Placentia,  CA  92670
Correspondent Contact K.C. CHEN, PH D.
Regulation Number862.1660
Classification Product Code
JJY  
Date Received12/30/1993
Decision Date 10/04/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
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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