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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 the device name listed in this FDA 510(k) record. The listed applicant is Ortho Clinical Diagnostics. It received FDA 510(k) clearance on 2017-05-16 under 510(k) 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. The listed applicant is Ortho Clinical Diagnostics. The 510(k) number is K171168.

When did VITROS Immunodiagnostic Products Insulin Calibrators receive FDA 510(k) clearance?

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

Who is the listed applicant for VITROS Immunodiagnostic Products Insulin Calibrators?

The FDA 510(k) record lists Ortho Clinical Diagnostics as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Ortho Clinical Diagnostics as applicant

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Related Devices (Code: 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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