Atlas FDA

DIMENSION VISTA ENZYMATIC CREATININE FLEX REAGENT CARTRIDGE, AND ENZYMATIC CREATININE CALIBRATOR, MODELS K1270, KC270

FDA 510(k) clearance K090330 · decided 2009-05-22

Clearance details

K-number
K090330
Device name
DIMENSION VISTA ENZYMATIC CREATININE FLEX REAGENT CARTRIDGE, AND ENZYMATIC CREATININE CALIBRATOR, MODELS K1270, KC270
Applicant
Siemens Healthcare Diagnostics, Inc.
Decision
Substantially Equivalent
Date received
2009-02-10
Decision date
2009-05-22
Days to decision
101 days
Clearance type
Traditional
Product code
JFY
Device class
2
Regulation number
862.1225
Medical specialty
Clinical Chemistry
Advisory committee
Clinical Chemistry
Location
Newark, DE, US
Third-party review
No
Expedited review
No

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