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FDA 510(k) Applications Submitted by ROSANNE M SAVOL
FDA 510(k) Number
Submission Date
Device Name
Applicant
K960546
02/08/1996
CLINITEK 50 URINE CHEMISTRY ANALYZER
BAYER CORP.
K960888
03/04/1996
CHEK-STIX U.T.I. SELF-TEST
BAYER CORP.
K971276
04/07/1997
GLUCOMETER ENCORE QA+ BLOOD GLUCOSE METER
BAYER CORP.
K982219
06/24/1998
MICROALBUSTIX REAGENT STRIPS
BAYER CORP.
K972706
07/21/1997
CLINITEK MICROALBUMIN REAGENT STRIPS
BAYER CORP.
K964630
11/19/1996
GLUCOMETER ELITE BLOOD GLUCOSE METER
BAYER CORP.
K963142
08/13/1996
DCA 2000 + MICROALBUMIN/CREATININE ASSAY
BAYER CORP.
K963500
09/03/1996
GLUCOMETER DEX DIABETES CARE SYSTEM
BAYER CORP.
K964004
10/07/1996
GLUCOMETER ENCORE BLOOD GLUCOSE TEST STRIPS
BAYER CORP.
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