FDA 510(k)

VITROS IMMUNODIAGNOSTIC PRODUCTS FREE T3 REAGENT PACK, VITROS IMMUNODIAGNOSTIC PRODUCTS FREE T3 CALIBRATORS

K-Number: K994145 · 1999-12-22

ApplicantOrtho-Clinical Diagnostics, Inc.

Decision Date1999-12-22

Product CodeJIS

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

VITROS IMMUNODIAGNOSTIC PRODUCTS FREE T3 REAGENT PACK, VITROS IMMUNODIAGNOSTIC PRODUCTS FREE T3 CALIBRATORS is the device name listed in this FDA 510(k) record. The listed applicant is Ortho-Clinical Diagnostics, Inc.. It received FDA 510(k) clearance on 1999-12-22 under 510(k) number K994145. The device is classified under product code JIS. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VITROS IMMUNODIAGNOSTIC PRODUCTS FREE T3 REAGENT PACK, VITROS IMMUNODIAGNOSTIC PRODUCTS FREE T3 CALIBRATORS?

VITROS IMMUNODIAGNOSTIC PRODUCTS FREE T3 REAGENT PACK, VITROS IMMUNODIAGNOSTIC PRODUCTS FREE T3 CALIBRATORS is a medical device that received FDA 510(k) clearance on 1999-12-22. The listed applicant is Ortho-Clinical Diagnostics, Inc.. The 510(k) number is K994145.

When did VITROS IMMUNODIAGNOSTIC PRODUCTS FREE T3 REAGENT PACK, VITROS IMMUNODIAGNOSTIC PRODUCTS FREE T3 CALIBRATORS receive FDA 510(k) clearance?

VITROS IMMUNODIAGNOSTIC PRODUCTS FREE T3 REAGENT PACK, VITROS IMMUNODIAGNOSTIC PRODUCTS FREE T3 CALIBRATORS received FDA 510(k) clearance on 1999-12-22, under 510(k) number K994145.

Who is the listed applicant for VITROS IMMUNODIAGNOSTIC PRODUCTS FREE T3 REAGENT PACK, VITROS IMMUNODIAGNOSTIC PRODUCTS FREE T3 CALIBRATORS?

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

What is the FDA product code for VITROS IMMUNODIAGNOSTIC PRODUCTS FREE T3 REAGENT PACK, VITROS IMMUNODIAGNOSTIC PRODUCTS FREE T3 CALIBRATORS?

The FDA product code for VITROS IMMUNODIAGNOSTIC PRODUCTS FREE T3 REAGENT PACK, VITROS IMMUNODIAGNOSTIC PRODUCTS FREE T3 CALIBRATORS is JIS.

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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.