Atlas FDA

DIMENSION VISTA CSAE CALIBRATOR, MODEL KC440

FDA 510(k) clearance K082030 · decided 2008-08-22

Clearance details

K-number
K082030
Device name
DIMENSION VISTA CSAE CALIBRATOR, MODEL KC440
Applicant
Siemens Healthcare Diagnostics, Inc.
Decision
Substantially Equivalent
Date received
2008-07-17
Decision date
2008-08-22
Days to decision
36 days
Clearance type
Traditional
Product code
DLJ
Device class
2
Regulation number
862.3200
Medical specialty
Clinical Toxicology
Advisory committee
Clinical Toxicology
Location
Newark, DE, US
Third-party review
No
Expedited review
No

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RecordFirmDate
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Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

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