Atlas FDA

VITROS Immunodiagnostic Products CK-MB Reagent Pack

FDA 510(k) clearance K212648 · decided 2022-01-28

Clearance details

K-number
K212648
Device name
VITROS Immunodiagnostic Products CK-MB Reagent Pack
Applicant
Ortho Clinical Diagnostics
Decision
Substantially Equivalent
Date received
2021-08-23
Decision date
2022-01-28
Days to decision
158 days
Clearance type
Traditional
Product code
JHX
Device class
2
Regulation number
862.1215
Medical specialty
Clinical Chemistry
Advisory committee
Clinical Chemistry
Location
Pencoed, GB
Third-party review
No
Expedited review
No

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STRATUS CS ACUTE CARE MB ISOENZYME OF CREATINE KINASE (CKMB) TEST PAK; STRATUS CS ACUTE CARE CKMB TESTPAK. (K051650)Dade Behring, Inc.2005-09-08
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MODIFICATION TO ALPHA DX SYSTEM (K013118)First Medical, Inc.2001-10-15
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Recalls involving this device

No recalls on record reference this clearance.

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