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FDA 510(k)

VITROS Immunodiagnostic Products Insulin Calibrators

K-Number: K171168 · 2017-05-16

ApplicantOrtho Clinical Diagnostics
Decision Date2017-05-16
Product CodeJIT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

VITROS Immunodiagnostic Products Insulin Calibrators is a medical device manufactured by Ortho Clinical Diagnostics. It received FDA 510(k) clearance on 2017-05-16 under approval number K171168. The device is classified under product code JIT. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VITROS Immunodiagnostic Products Insulin Calibrators?

VITROS Immunodiagnostic Products Insulin Calibrators is a medical device that received FDA 510(k) clearance on 2017-05-16. It is manufactured by Ortho Clinical Diagnostics. The 510(k) number is K171168.

When was VITROS Immunodiagnostic Products Insulin Calibrators approved by the FDA?

VITROS Immunodiagnostic Products Insulin Calibrators received FDA 510(k) clearance on 2017-05-16, under approval number K171168.

What company makes VITROS Immunodiagnostic Products Insulin Calibrators?

VITROS Immunodiagnostic Products Insulin Calibrators is manufactured by Ortho Clinical Diagnostics.

What is the FDA product code for VITROS Immunodiagnostic Products Insulin Calibrators?

The FDA product code for VITROS Immunodiagnostic Products Insulin Calibrators is JIT.

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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.

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