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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calibrator, Surrogate
510(k) Number K851450
Device Name FLUORESCENT MICROBEAD ALIGNMENT STANDARDS TM
Applicant
Flow Cytometry Standards Corp.
P.O. Box 12621
Research Triangle Park,  NC  27709
Applicant Contact SCHWARTZ
Correspondent
Flow Cytometry Standards Corp.
P.O. Box 12621
Research Triangle Park,  NC  27709
Correspondent Contact SCHWARTZ
Regulation Number862.1150
Classification Product Code
JIW  
Date Received04/11/1985
Decision Date 09/16/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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