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FDA 510(k) Applications Submitted by KELLY COLLEEN O'MAINE ADAMS
FDA 510(k) Number
Submission Date
Device Name
Applicant
K100810
03/22/2010
ELECSYS C-PEPTIDE CALCHECK 5
Roche Diagnostics
K102044
07/21/2010
ELECSYS DIGOXIN CALCHECK 5
Roche Diagnostics
K101365
05/17/2010
ELECSYS CA 19-9 CALCHECK 5
ROCHE DIAGNOSTICS CORP.
K103221
11/01/2010
ELECYS HGH CALSET, ELECSYS HGH CALCHECK 5
Roche Diagnostics
K103402
11/19/2010
ELECSYS DHEA-S CALCHECK 5
Roche Diagnostics
K093700
12/01/2009
ELECSYS HCG STAT CALCHECK 5
ROCHE DIAGNOSTICS CORP.
K094031
12/30/2009
ELECSYS FOLATE III CALCHECK 5
Roche Diagnostics
K110613
03/03/2011
ELECSYS PROLACTIN II CALCHECK 5
Roche Diagnostics
K112113
07/25/2011
ELECSYS MYOGLOBIN CALCHECK 5
Roche Diagnostics
K093836
12/15/2009
ELECSYS TSH CALCHECK 5
Roche Diagnostics
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