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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Colorimeter, Photometer, Spectrophotometer For Clinical Use
510(k) Number K914202
Device Name BARTELS PRIMA SYSTEM ADVANCED SCREENING CARTRIDGE
Applicant
Baxter Diagnostics, Inc.
Bartels Diagnostics Division
P.O. Box 3093
Bellevue,  WA  98009
Applicant Contact JS MALLINAK
Correspondent
Baxter Diagnostics, Inc.
Bartels Diagnostics Division
P.O. Box 3093
Bellevue,  WA  98009
Correspondent Contact JS MALLINAK
Regulation Number862.2300
Classification Product Code
JJQ  
Date Received09/19/1991
Decision Date 10/11/1991
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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