Atlas FDA

CONTOUR NEXT BLOOD GLUCOSE METER

FDA 510(k) clearance K121190 · decided 2012-07-26

Clearance details

K-number
K121190
Device name
CONTOUR NEXT BLOOD GLUCOSE METER
Applicant
Bayer Healthcare, LLC
Decision
Substantially Equivalent
Date received
2012-04-19
Decision date
2012-07-26
Days to decision
98 days
Clearance type
Special
Product code
LFR
Device class
2
Regulation number
862.1345
Medical specialty
Clinical Chemistry
Advisory committee
Clinical Chemistry
Location
Tarrytown, NY, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
ADVIA CENTAUR HAV IGM READY PACK REAGENTS, ADVIA CENTAUR HAV IGM QUALITY CONTROL MATERIALS (P040018)Bayer Healthcare, LLC2004-12-22
CIBA CORNING ACS PSA IMMUNOASSAY (P920030/S002)Bayer Healthcare, LLC1998-12-08
CIBA CORNING ACS PSA IMMUNOASSAY (P920030)Bayer Healthcare, LLC1998-12-08
CIBA CORNING ACS PSA IMMUNOASSAY (P920030/S001)Bayer Healthcare, LLC1995-12-13