Atlas FDA

BAYER SPECIFIC PROTEIN REFERENCE SERUM

FDA 510(k) clearance K033791 · decided 2004-02-13

Clearance details

K-number
K033791
Device name
BAYER SPECIFIC PROTEIN REFERENCE SERUM
Applicant
Bayer Healthcare, LLC
Decision
Substantially Equivalent
Date received
2003-12-04
Decision date
2004-02-13
Days to decision
71 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

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