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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Station, Pipetting And Diluting, For Clinical Use
510(k) Number K923268
Device Name AFFIRM PROCESSOR
Applicant
Microprobe Corp.
7390 Lincoln Way
Garden Grove,  CA  92641
Applicant Contact RUSSEL K ENNS
Correspondent
Microprobe Corp.
7390 Lincoln Way
Garden Grove,  CA  92641
Correspondent Contact RUSSEL K ENNS
Regulation Number862.2750
Classification Product Code
JQW  
Date Received07/06/1992
Decision Date 07/30/1992
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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