Atlas FDA

ARCHITECT B12

FDA 510(k) clearance K121314 · decided 2012-05-17

Clearance details

K-number
K121314
Device name
ARCHITECT B12
Applicant
Abbott Laboratories
Decision
Substantially Equivalent
Date received
2012-05-02
Decision date
2012-05-17
Days to decision
15 days
Clearance type
Traditional
Product code
CDD
Device class
2
Regulation number
862.1810
Medical specialty
Clinical Chemistry
Advisory committee
Clinical Chemistry
Location
Abbott Park, IL, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
ARCHITECT Active-B12 (Holotranscobalamin) (K233541)Axis-Shield Diagnostics, Ltd.2024-07-31
Access Vitamin B12 (K223289)Beckman Coulter, Inc.2022-12-23
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LIAISON Vitamin B12 (K192064)DiaSorin, Inc.2019-10-02
ADVIA Centaur Active-B12 (Holotranscobalamin) (AB12) Assay (K172133)Axis-Shield Diagnostics, Ltd.2017-10-27
Diazyme Vitamin B12 Assay, Diazyme Vitamin B12 Calibrators Set, Diazyme Vitamin B12 Controls Set (K161721)Diazyme Laboratories2016-09-20
ADVIA Centaur Active-B12 (Holotranscobalamin)(AB12) Assay, ADVIA Centaur Active-B12(AB12) Quality Control, and ADVIA Centaur Active-B12 (AB12) Master Curve Materials (MCM) (K160757)Axis-Shield Diagnostics Limited2016-07-26
Elecsys Vitamin B12 II assay, Elecsys Vitamin B12 II CalSet (K151786)Roche Diagnostics2015-09-24
Access Vitamin B12 Assay, Access Ferritin Assay, Access Folate Assay, Access HYPERsensitive hTSH Assay, Power Express Sample Processing System Generic Connection Module and Access Immunoassay System Reagents (K140496)Beckman Coulter, Inc.2014-09-16
LOCI VITAMIN B12 (VB12) FLEX REAGENT CARTRIDGE, LOCI ANEMIA CALIBRATOR (ANEM CAL) (K133512)Siemens Healthcare Diagnostics2014-01-02
AXIS-SHIELD ACVTIVE-B12 (K121946)Axis-Shield Diagnostics, Ltd.2013-03-22
DIMENSION VISTA VITAMIN B12 (VB12) FLEX REAGENT CARTRIDGE, DIMENSION VISTA LOCI 4 CALIBRATOR (K121994)Siemens Healthcare Diagnostics, Inc.2012-11-30

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
ARCHITECT CORE / Alinity i Anti-HBc (P080023/S046)Abbott Laboratories2025-04-03
ARCHITECT AFP / Alinity i AFP (P120008/S030)Abbott Laboratories2025-04-03
ARCHITECT CORE-M / Alinity i Anti-HBc IgM (P060035/S043)Abbott Laboratories2025-04-03
ARCHITECT Total PSA / Alinity i Total PSA (P910007/S066)Abbott Laboratories2025-04-03
ARCHITECT Free PSA / Alinity i Free PSA (P980007/S055)Abbott Laboratories2025-04-03
ARCHITECT HBsAg Qualitative/Qualitative Confirmatory / Alinity i HBsAg Qualitative II/Qualitative II Confirmatory (P110029/S052)Abbott Laboratories2025-04-03
ARCHITECT HBsAg Next Qualitative / ARCHITECT HBsAg Next Confirmatory/ Alinity i HBsAg Next Qualitative/Alinity i HBsAg N (P210003/S013)Abbott Laboratories2025-04-03
ARCHITECT HBsAg Next Qualitative/Next Confirmatory, Alinity i HBsAg Next Qualitative/Next Confirmatory (P210003/S012)Abbott Laboratories2024-09-30