Atlas FDA

DIMENSION VISTA LG LIGHT CHAINS, TYPE KAPPA, DIMENSION VISTA LG LIGHT CHAINS, TYPE LAMBDA, DIMENSION VISTA PROTEIN 1 CAL

FDA 510(k) clearance K082503 · decided 2008-12-19

Clearance details

K-number
K082503
Device name
DIMENSION VISTA LG LIGHT CHAINS, TYPE KAPPA, DIMENSION VISTA LG LIGHT CHAINS, TYPE LAMBDA, DIMENSION VISTA PROTEIN 1 CAL
Applicant
Siemens Healthcare Diagnostics
Decision
Substantially Equivalent
Date received
2008-08-29
Decision date
2008-12-19
Days to decision
112 days
Clearance type
Traditional
Product code
DFH
Device class
2
Regulation number
866.5550
Medical specialty
Immunology
Advisory committee
Immunology
Location
Newark, DE, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.

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