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FDA 510(k)

QUANTICOAT NEONATAL 125 T4 RADIOIMMUNO

K-Number: K812611 · 1981-10-02

ApplicantKallestad Laboratories, Inc.
Decision Date1981-10-02
Product CodeCDP
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

QUANTICOAT NEONATAL 125 T4 RADIOIMMUNO 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 1981-10-02 under 510(k) number K812611. 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 QUANTICOAT NEONATAL 125 T4 RADIOIMMUNO?

QUANTICOAT NEONATAL 125 T4 RADIOIMMUNO is a medical device that received FDA 510(k) clearance on 1981-10-02. The listed applicant is Kallestad Laboratories, Inc.. The 510(k) number is K812611.

When did QUANTICOAT NEONATAL 125 T4 RADIOIMMUNO receive FDA 510(k) clearance?

QUANTICOAT NEONATAL 125 T4 RADIOIMMUNO received FDA 510(k) clearance on 1981-10-02, under 510(k) number K812611.

Who is the listed applicant for QUANTICOAT NEONATAL 125 T4 RADIOIMMUNO?

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 QUANTICOAT NEONATAL 125 T4 RADIOIMMUNO?

The FDA product code for QUANTICOAT NEONATAL 125 T4 RADIOIMMUNO is CDP.

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Other records listing Kallestad Laboratories, Inc. as applicant

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Related Devices (Code: CDP)

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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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