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FDA 510(k)

GAMMA DAB[125I]PTH RADIOIMMUNOASSAY KIT

K-Number: K822944 · 1982-12-30

ApplicantTravenol Laboratories, S.A.
Decision Date1982-12-30
Product CodeCEW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

GAMMA DAB[125I]PTH RADIOIMMUNOASSAY KIT is the device name listed in this FDA 510(k) record. The listed applicant is Travenol Laboratories, S.A.. It received FDA 510(k) clearance on 1982-12-30 under 510(k) number K822944. The device is classified under product code CEW. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GAMMA DAB[125I]PTH RADIOIMMUNOASSAY KIT?

GAMMA DAB[125I]PTH RADIOIMMUNOASSAY KIT is a medical device that received FDA 510(k) clearance on 1982-12-30. The listed applicant is Travenol Laboratories, S.A.. The 510(k) number is K822944.

When did GAMMA DAB[125I]PTH RADIOIMMUNOASSAY KIT receive FDA 510(k) clearance?

GAMMA DAB[125I]PTH RADIOIMMUNOASSAY KIT received FDA 510(k) clearance on 1982-12-30, under 510(k) number K822944.

Who is the listed applicant for GAMMA DAB[125I]PTH RADIOIMMUNOASSAY KIT?

The FDA 510(k) record lists Travenol Laboratories, S.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GAMMA DAB[125I]PTH RADIOIMMUNOASSAY KIT?

The FDA product code for GAMMA DAB[125I]PTH RADIOIMMUNOASSAY KIT is CEW.

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Related Devices (Code: CEW)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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