Atlas FDA

N ANTISERA TO HUMAN IMMUNOGLOBULINS (IGG, IGA AND IGM) AND N/T PROTEIN CONTROL LC

FDA 510(k) clearance K083445 · decided 2009-03-24

Clearance details

K-number
K083445
Device name
N ANTISERA TO HUMAN IMMUNOGLOBULINS (IGG, IGA AND IGM) AND N/T PROTEIN CONTROL LC
Applicant
Siemens Healthcare Diagnostics
Decision
Substantially Equivalent
Date received
2008-11-21
Decision date
2009-03-24
Days to decision
123 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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