Atlas FDA

B12 REAGENT CARTRIDGE AND FOL FLEX REAGENT CARTRIDGE, MODEL RF642 AND RF644

FDA 510(k) clearance K093631 · decided 2010-02-12

Clearance details

K-number
K093631
Device name
B12 REAGENT CARTRIDGE AND FOL FLEX REAGENT CARTRIDGE, MODEL RF642 AND RF644
Applicant
Siemens Healthcare Diagnostics
Decision
Substantially Equivalent
Date received
2009-11-24
Decision date
2010-02-12
Days to decision
80 days
Clearance type
Special
Product code
CDD
Device class
2
Regulation number
862.1810
Medical specialty
Clinical Chemistry
Advisory committee
Clinical Chemistry
Location
Newark, DE, US
Third-party review
No
Expedited review
No

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

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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
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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.

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