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FDA 510(k)

RADIOIMMUNOASSAY KIT(CORTISOL IN PLASMA)

K-Number: K761346 · 1977-01-07

ApplicantNew England Nuclear
Decision Date1977-01-07
Product CodeCGR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

RADIOIMMUNOASSAY KIT(CORTISOL IN PLASMA) 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 1977-01-07 under 510(k) number K761346. The device is classified under product code CGR. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RADIOIMMUNOASSAY KIT(CORTISOL IN PLASMA)?

RADIOIMMUNOASSAY KIT(CORTISOL IN PLASMA) is a medical device that received FDA 510(k) clearance on 1977-01-07. The listed applicant is New England Nuclear. The 510(k) number is K761346.

When did RADIOIMMUNOASSAY KIT(CORTISOL IN PLASMA) receive FDA 510(k) clearance?

RADIOIMMUNOASSAY KIT(CORTISOL IN PLASMA) received FDA 510(k) clearance on 1977-01-07, under 510(k) number K761346.

Who is the listed applicant for RADIOIMMUNOASSAY KIT(CORTISOL IN PLASMA)?

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 RADIOIMMUNOASSAY KIT(CORTISOL IN PLASMA)?

The FDA product code for RADIOIMMUNOASSAY KIT(CORTISOL IN PLASMA) is CGR.

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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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