Atlas FDA

DIMENSION VISTA IMMUNOGLOBULIN A FLEX REAGENT CARTRIDGE (IGA), AND DIMENSION VISTA IMMUNOGLOBULIN M FLEX REAGENT CARTRID

FDA 510(k) clearance K090594 · decided 2009-04-29

Clearance details

K-number
K090594
Device name
DIMENSION VISTA IMMUNOGLOBULIN A FLEX REAGENT CARTRIDGE (IGA), AND DIMENSION VISTA IMMUNOGLOBULIN M FLEX REAGENT CARTRID
Applicant
Siemens Healthcare Diagnostics
Decision
Substantially Equivalent
Date received
2009-03-05
Decision date
2009-04-29
Days to decision
55 days
Clearance type
Traditional
Product code
CFN
Device class
2
Regulation number
866.5510
Medical specialty
Immunology
Advisory committee
Immunology
Location
Newark, DE, US
Third-party review
No
Expedited review
No

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Optilite IgM CSF Kit (K190686)The Binding Site Group , Ltd.2019-05-28
Optilite IgA CSF Kit (K183151)The Binding Site Group , Ltd.2019-01-23
DxC 700 AU Clinical Chemistry Analyzer, AU IgG Reagent (K162208)Beckman Coulter, Inc.2017-01-09
Optilite IgG4 Kit (K150526)The Binding Site Group , Ltd.2015-05-30
The Optilite IgG3 kit (K142735)The Binding Site Group , Ltd.2014-12-21
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Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

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