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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bilirubin (Total And Unbound) In The Neonate Test System
510(k) Number K922770
Device Name UNISTAT BILIRUBINOMETER MODELS 10310 AND 10311
Applicant
Leica, Inc.
203 Eggert Rd.
Buffalo,  NY  14215
Applicant Contact JOHN CROCKER
Correspondent
Leica, Inc.
203 Eggert Rd.
Buffalo,  NY  14215
Correspondent Contact JOHN CROCKER
Regulation Number862.1113
Classification Product Code
MQM  
Date Received06/09/1992
Decision Date 08/18/1992
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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