Atlas FDA

VITROS Chemistry Products CRP Slides; VITRO Chemistry Products Calibrator Kit 7

FDA 510(k) clearance K152433 · decided 2015-09-24

Clearance details

K-number
K152433
Device name
VITROS Chemistry Products CRP Slides; VITRO Chemistry Products Calibrator Kit 7
Applicant
Ortho Clinical Diagnostics
Decision
Substantially Equivalent
Date received
2015-08-27
Decision date
2015-09-24
Days to decision
28 days
Clearance type
Special
Product code
DCK
Device class
2
Regulation number
866.5270
Medical specialty
Immunology
Advisory committee
Immunology
Location
Rochester, NY, US
Third-party review
No
Expedited review
No

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Devices cleared under the same product code - the starting set for predicate research.

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Recalls involving this device

RecordFirmDate
VITROS Chemistry Products CRP Slides. One sales unit contains 5 cartridges, of 18 slides p recall (Z-1876-2025)Ortho-Clinical Diagnostics, Inc.2025-05-29
VITROS Chemistry Products CRP Slides- In vitro diagnostic quantitatively measures C-reacti recall (Z-0535-2025)Ortho-Clinical Diagnostics, Inc.2024-11-25

PMA approvals by this applicant

RecordFirmDate
VITROS Immunodiagnostic Products Anti-HBe Reagent Pack and Calibrator (P100001/S017)Ortho-Clinical Diagnostics2023-01-24
VITROS Anti-HBe (P100001/S016)Ortho-Clinical Diagnostics2019-06-19
VITROS Anti-HBc (P030024/S029)Ortho-Clinical Diagnostics2019-06-19
VITROS Immunodiagnostic Products Anti-HBc Reagent Pack and Calibrator (P030024/S028)Ortho-Clinical Diagnostics2018-12-17
VITROS Immunodiagnostic Products Anti-HBe Reagent Pack and Calibrator (P100001/S015)Ortho-Clinical Diagnostics2018-12-17
VITROS Immunodiagnostic Products Anti-HBc Reagent Pack and Calibrator (P030024/S027)Ortho-Clinical Diagnostics2018-10-16
VITROS Immunodiagnostic Products Anti-HBc Reagent Pack and Calibrator (P030024/S025)Ortho-Clinical Diagnostics2018-07-02
VITROS Immunodiagnostic Products Anti-HBc Reagent Pack and Calibrator (P030024/S026)Ortho-Clinical Diagnostics2018-07-02