Atlas FDA

DIMENSION CKI FLEX REAGENT CARTRIDGE, DIMENSION MBI FLEX REAGENT CARTRIDGE, AND CKI/MBI CALIBRATOR, MODELS DF38, DF32

FDA 510(k) clearance K081731 · decided 2008-08-29

Clearance details

K-number
K081731
Device name
DIMENSION CKI FLEX REAGENT CARTRIDGE, DIMENSION MBI FLEX REAGENT CARTRIDGE, AND CKI/MBI CALIBRATOR, MODELS DF38, DF32
Applicant
Siemens Healthcare Diagnostics
Decision
Substantially Equivalent
Date received
2008-06-19
Decision date
2008-08-29
Days to decision
71 days
Clearance type
Traditional
Product code
CGS
Device class
2
Regulation number
862.1215
Medical specialty
Clinical Chemistry
Advisory committee
Clinical Chemistry
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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