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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Single (Specified) Analyte Controls (Assayed And Unassayed)
510(k) Number K990393
Device Name ARCHITECT PROGESTERONE MASTERCHECK MODEL #6C26-05
Applicant
Bio-Rad
9500 Jeronimo Rd.
Irvine,  CA  92618 -2017
Applicant Contact ELIZABETH PLATT
Correspondent
Bio-Rad
9500 Jeronimo Rd.
Irvine,  CA  92618 -2017
Correspondent Contact ELIZABETH PLATT
Regulation Number862.1660
Classification Product Code
JJX  
Date Received02/09/1999
Decision Date 03/22/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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