FDA 510(k)

125 I-T3 UPTAKE REAGENT

K-Number: K780671 · 1978-06-06

Decision Date1978-06-06

Product CodeCEE

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

125 I-T3 UPTAKE REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Radioimmunoassay, Inc.. It received FDA 510(k) clearance on 1978-06-06 under 510(k) number K780671. The device is classified under product code CEE. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 125 I-T3 UPTAKE REAGENT?

125 I-T3 UPTAKE REAGENT is a medical device that received FDA 510(k) clearance on 1978-06-06. The listed applicant is Radioimmunoassay, Inc.. The 510(k) number is K780671.

When did 125 I-T3 UPTAKE REAGENT receive FDA 510(k) clearance?

125 I-T3 UPTAKE REAGENT received FDA 510(k) clearance on 1978-06-06, under 510(k) number K780671.

Who is the listed applicant for 125 I-T3 UPTAKE REAGENT?

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

What is the FDA product code for 125 I-T3 UPTAKE REAGENT?

The FDA product code for 125 I-T3 UPTAKE REAGENT is CEE.

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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.