Atlas FDA

DIMENSION VISTA LOCI CA 125 FLEX REAGENT CARTRIDGE,AND DIMENSIONS VISTA LOCI 6 CAL, MODEL#'S K6455, AND KC604

FDA 510(k) clearance K100321 · decided 2011-04-12

Clearance details

K-number
K100321
Device name
DIMENSION VISTA LOCI CA 125 FLEX REAGENT CARTRIDGE,AND DIMENSIONS VISTA LOCI 6 CAL, MODEL#'S K6455, AND KC604
Applicant
Siemens Healthcare Diagnostics
Decision
Substantially Equivalent
Date received
2010-02-04
Decision date
2011-04-12
Days to decision
432 days
Clearance type
Traditional
Product code
LTK
Device class
2
Regulation number
866.6010
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.

PMA approvals by this applicant

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