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FDA 510(k)

SIMULTRAC FREE T4[57CO]/TSH MAB[125I]

K-Number: K864838 · 1987-02-18

ApplicantBd Becton Dickinson Vacutainer Systems Preanalytic
Decision Date1987-02-18
Product CodeCEC
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SIMULTRAC FREE T4[57CO]/TSH MAB[125I] is the device name listed in this FDA 510(k) record. The listed applicant is Bd Becton Dickinson Vacutainer Systems Preanalytic. It received FDA 510(k) clearance on 1987-02-18 under 510(k) number K864838. The device is classified under product code CEC. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SIMULTRAC FREE T4[57CO]/TSH MAB[125I]?

SIMULTRAC FREE T4[57CO]/TSH MAB[125I] is a medical device that received FDA 510(k) clearance on 1987-02-18. The listed applicant is Bd Becton Dickinson Vacutainer Systems Preanalytic. The 510(k) number is K864838.

When did SIMULTRAC FREE T4[57CO]/TSH MAB[125I] receive FDA 510(k) clearance?

SIMULTRAC FREE T4[57CO]/TSH MAB[125I] received FDA 510(k) clearance on 1987-02-18, under 510(k) number K864838.

Who is the listed applicant for SIMULTRAC FREE T4[57CO]/TSH MAB[125I]?

The FDA 510(k) record lists Bd Becton Dickinson Vacutainer Systems Preanalytic as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SIMULTRAC FREE T4[57CO]/TSH MAB[125I]?

The FDA product code for SIMULTRAC FREE T4[57CO]/TSH MAB[125I] is CEC.

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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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