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FDA 510(k)

TESTOSTERONE RADIOIMMUNOASSY KIT

K-Number: K802135 · 1980-10-10

ApplicantRadioimmunoassay, Inc.
Decision Date1980-10-10
Product CodeCDZ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

TESTOSTERONE RADIOIMMUNOASSY KIT is the device name listed in this FDA 510(k) record. The listed applicant is Radioimmunoassay, Inc.. It received FDA 510(k) clearance on 1980-10-10 under 510(k) number K802135. The device is classified under product code CDZ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TESTOSTERONE RADIOIMMUNOASSY KIT?

TESTOSTERONE RADIOIMMUNOASSY KIT is a medical device that received FDA 510(k) clearance on 1980-10-10. The listed applicant is Radioimmunoassay, Inc.. The 510(k) number is K802135.

When did TESTOSTERONE RADIOIMMUNOASSY KIT receive FDA 510(k) clearance?

TESTOSTERONE RADIOIMMUNOASSY KIT received FDA 510(k) clearance on 1980-10-10, under 510(k) number K802135.

Who is the listed applicant for TESTOSTERONE RADIOIMMUNOASSY KIT?

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

What is the FDA product code for TESTOSTERONE RADIOIMMUNOASSY KIT?

The FDA product code for TESTOSTERONE RADIOIMMUNOASSY KIT is CDZ.

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Other records listing Radioimmunoassay, Inc. as applicant

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Related Devices (Code: CDZ)

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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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