FDA 510(k)

PHASE II FREE T4 KIT

K-Number: K840901 · 1984-04-25

ApplicantMedical & Scientific Designs, Inc.

Decision Date1984-04-25

Product CodeCEC

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

PHASE II FREE T4 KIT is the device name listed in this FDA 510(k) record. The listed applicant is Medical & Scientific Designs, Inc.. It received FDA 510(k) clearance on 1984-04-25 under 510(k) number K840901. 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 PHASE II FREE T4 KIT?

PHASE II FREE T4 KIT is a medical device that received FDA 510(k) clearance on 1984-04-25. The listed applicant is Medical & Scientific Designs, Inc.. The 510(k) number is K840901.

When did PHASE II FREE T4 KIT receive FDA 510(k) clearance?

PHASE II FREE T4 KIT received FDA 510(k) clearance on 1984-04-25, under 510(k) number K840901.

Who is the listed applicant for PHASE II FREE T4 KIT?

The FDA 510(k) record lists Medical & Scientific Designs, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PHASE II FREE T4 KIT?

The FDA product code for PHASE II FREE T4 KIT 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.