Atlas FDA

VITROS CHEMISTRY PRODUCT NA+ SLIDES; VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 2

FDA 510(k) clearance K081411 · decided 2008-06-30

Clearance details

K-number
K081411
Device name
VITROS CHEMISTRY PRODUCT NA+ SLIDES; VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 2
Applicant
Ortho-Clinical Diagnostics, Inc.
Decision
Substantially Equivalent
Date received
2008-05-20
Decision date
2008-06-30
Days to decision
41 days
Clearance type
Special
Product code
JGS
Device class
2
Regulation number
862.1665
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 Na+ Slides, manufactured by Ortho Clinical Diagnostics 513 Techn recall (Z-1087-2014)Ortho-Clinical Diagnostics2014-02-25
VITROS Chemistry Products Calibrator Kit 2, manufactured by Ortho Clinical Diagnostics 100 recall (Z-1088-2014)Ortho-Clinical Diagnostics2014-02-25

PMA approvals by this applicant

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