Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

VITROS AFP

K-Number: K213626 · 2022-06-15

ApplicantOrtho Clinical Diagnostics
Decision Date2022-06-15
Product CodeLOJ
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

VITROS AFP is a medical device manufactured by Ortho Clinical Diagnostics. It received FDA 510(k) clearance on 2022-06-15 under approval number K213626. The device is classified under product code LOJ. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VITROS AFP?

VITROS AFP is a medical device that received FDA 510(k) clearance on 2022-06-15. It is manufactured by Ortho Clinical Diagnostics. The 510(k) number is K213626.

When was VITROS AFP approved by the FDA?

VITROS AFP received FDA 510(k) clearance on 2022-06-15, under approval number K213626.

What company makes VITROS AFP?

VITROS AFP is manufactured by Ortho Clinical Diagnostics.

What is the FDA product code for VITROS AFP?

The FDA product code for VITROS AFP is LOJ.

Other Devices by Ortho Clinical Diagnostics

K162020VITROS Chemistry Products Cl- Slides K163433VITROS Chemistry Products GLU Slides K160712VITROS Chemistry Products hsCRP Reagent K171168VITROS Immunodiagnostic Products Insulin Calibrators K200236VITROS BRAHMS PCT Reagent Pack and Calibrators K201312VITROS Immunodiagnostic Products NT-proBNP II Reagent Pack

View all 14 devices →

Related Devices (Code: LOJ)

K220176Elecsys AFPRoche Diagnostics

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.

↑