Atlas FDA

TOX AMMONIA CALIBRATOR

FDA 510(k) clearance K031683 · decided 2003-08-06

Clearance details

K-number
K031683
Device name
TOX AMMONIA CALIBRATOR
Applicant
Bayer Healthcare, LLC
Decision
Substantially Equivalent
Date received
2003-05-30
Decision date
2003-08-06
Days to decision
68 days
Clearance type
Abbreviated
Product code
JIX
Device class
2
Regulation number
862.1150
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

RecordFirmDate
ADVIA Chemistry ToxAmmonia Calibrator- In vitro diagnostic use in the calibration of ethan recall (Z-1631-2023)Siemens Healthcare Diagnostics, Inc.2023-05-25

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