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FDA 510(k)

RADIOIMMUNOASSAY, QUANTITIPE 125-I-T3

K-Number: K770520 · 1977-06-03

ApplicantKallestad Laboratories, Inc.
Decision Date1977-06-03
Product CodeCDP
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

RADIOIMMUNOASSAY, QUANTITIPE 125-I-T3 is the device name listed in this FDA 510(k) record. The listed applicant is Kallestad Laboratories, Inc.. It received FDA 510(k) clearance on 1977-06-03 under 510(k) number K770520. The device is classified under product code CDP. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RADIOIMMUNOASSAY, QUANTITIPE 125-I-T3?

RADIOIMMUNOASSAY, QUANTITIPE 125-I-T3 is a medical device that received FDA 510(k) clearance on 1977-06-03. The listed applicant is Kallestad Laboratories, Inc.. The 510(k) number is K770520.

When did RADIOIMMUNOASSAY, QUANTITIPE 125-I-T3 receive FDA 510(k) clearance?

RADIOIMMUNOASSAY, QUANTITIPE 125-I-T3 received FDA 510(k) clearance on 1977-06-03, under 510(k) number K770520.

Who is the listed applicant for RADIOIMMUNOASSAY, QUANTITIPE 125-I-T3?

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

What is the FDA product code for RADIOIMMUNOASSAY, QUANTITIPE 125-I-T3?

The FDA product code for RADIOIMMUNOASSAY, QUANTITIPE 125-I-T3 is CDP.

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Other records listing Kallestad Laboratories, Inc. as applicant

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Related Devices (Code: CDP)

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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