Atlas FDA

KODAK EKTACHEM CLINICAL CHEMISTRY SLIDE FOR ASPARATE AMIMOTRANSFERASE

FDA 510(k) clearance K934413 · decided 1994-04-25

Clearance details

K-number
K934413
Device name
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDE FOR ASPARATE AMIMOTRANSFERASE
Applicant
Eastman Kodak Company
Decision
Substantially Equivalent
Date received
1993-09-10
Decision date
1994-04-25
Days to decision
227 days
Clearance type
Traditional
Product code
CIT
Device class
2
Regulation number
862.1100
Medical specialty
Clinical Chemistry
Advisory committee
Clinical Chemistry
Location
Rochester, NY, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
VITROS Chemistry Products AST Slides packaged as 300 slides/pack catalog number 8433815 VI recall (Z-0299-2014)Ortho-Clinical Diagnostics2013-11-15