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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Automated Radioimmunoassay Systems, For Clinical Use
510(k) Number K801037
Device Name CENTRIA SYSTEM 2 AUTOMATED METHOD/RIA
Applicant
Union Carbide Corp.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Union Carbide Corp.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number862.2050
Classification Product Code
LCI  
Date Received05/02/1980
Decision Date 05/28/1980
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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