VITROS Immunodiagnostic Products CK-MB Reagent Pack
K-Number: K212648 · 2022-01-28
ApplicantOrtho Clinical Diagnostics
Decision Date2022-01-28
Product CodeJHX
Advisory CommitteeCH
DecisionSubstantially Equivalent
Device Summary
VITROS Immunodiagnostic Products CK-MB Reagent Pack is a medical device manufactured by Ortho Clinical Diagnostics. It received FDA 510(k) clearance on 2022-01-28 under approval number K212648. The device is classified under product code JHX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the VITROS Immunodiagnostic Products CK-MB Reagent Pack?
VITROS Immunodiagnostic Products CK-MB Reagent Pack is a medical device that received FDA 510(k) clearance on 2022-01-28. It is manufactured by Ortho Clinical Diagnostics. The 510(k) number is K212648.
When was VITROS Immunodiagnostic Products CK-MB Reagent Pack approved by the FDA?
VITROS Immunodiagnostic Products CK-MB Reagent Pack received FDA 510(k) clearance on 2022-01-28, under approval number K212648.
What company makes VITROS Immunodiagnostic Products CK-MB Reagent Pack?
VITROS Immunodiagnostic Products CK-MB Reagent Pack is manufactured by Ortho Clinical Diagnostics.
What is the FDA product code for VITROS Immunodiagnostic Products CK-MB Reagent Pack?
The FDA product code for VITROS Immunodiagnostic Products CK-MB Reagent Pack is JHX.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.