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FDA 510(k)

RADIO IMMUNO ASSAY KIT/

K-Number: K760619 · 1976-12-06

ApplicantNew England Nuclear
Decision Date1976-12-06
Product CodeCDD
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

RADIO IMMUNO ASSAY KIT/ is the device name listed in this FDA 510(k) record. The listed applicant is New England Nuclear. It received FDA 510(k) clearance on 1976-12-06 under 510(k) number K760619. The device is classified under product code CDD. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RADIO IMMUNO ASSAY KIT/?

RADIO IMMUNO ASSAY KIT/ is a medical device that received FDA 510(k) clearance on 1976-12-06. The listed applicant is New England Nuclear. The 510(k) number is K760619.

When did RADIO IMMUNO ASSAY KIT/ receive FDA 510(k) clearance?

RADIO IMMUNO ASSAY KIT/ received FDA 510(k) clearance on 1976-12-06, under 510(k) number K760619.

Who is the listed applicant for RADIO IMMUNO ASSAY KIT/?

The FDA 510(k) record lists New England Nuclear as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RADIO IMMUNO ASSAY KIT/?

The FDA product code for RADIO IMMUNO ASSAY KIT/ is CDD.

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Other records listing New England Nuclear as applicant

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Related Devices (Code: CDD)

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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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