Atlas FDA

VITRO CHEMISTRY PRODUCTS ECO2 SLIDE & CALIBRATOR KIT 2

FDA 510(k) clearance K001133 · decided 2000-04-24

Clearance details

K-number
K001133
Device name
VITRO CHEMISTRY PRODUCTS ECO2 SLIDE & CALIBRATOR KIT 2
Applicant
Ortho-Clinical Diagnostics, Inc.
Decision
Substantially Equivalent
Date received
2000-04-10
Decision date
2000-04-24
Days to decision
14 days
Clearance type
Special
Product code
KHS
Device class
2
Regulation number
862.1160
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 ECO2 Slides packaged as 300 slides/pack catalog number 8262396 V recall (Z-0312-2014)Ortho-Clinical Diagnostics2013-11-15

PMA approvals by this applicant

RecordFirmDate
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VITROS Anti-HBs (P000014/S035)Ortho-Clinical Diagnostics, Inc.2019-06-19
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VITROS Anti-HBc IgM (P030026/S036)Ortho-Clinical Diagnostics, Inc.2019-06-19
VITROS HBeAg (P090028/S017)Ortho-Clinical Diagnostics, Inc.2019-06-19