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FDA 510(k)

GAMMA COAT ASSAY TESTOSTERONE RADIOIMMUNOASSAY KIT

K-Number: K915570 · 1992-01-27

ApplicantIncstar Corp.
Decision Date1992-01-27
Product CodeCDZ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

GAMMA COAT ASSAY TESTOSTERONE RADIOIMMUNOASSAY KIT is the device name listed in this FDA 510(k) record. The listed applicant is Incstar Corp.. It received FDA 510(k) clearance on 1992-01-27 under 510(k) number K915570. 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 GAMMA COAT ASSAY TESTOSTERONE RADIOIMMUNOASSAY KIT?

GAMMA COAT ASSAY TESTOSTERONE RADIOIMMUNOASSAY KIT is a medical device that received FDA 510(k) clearance on 1992-01-27. The listed applicant is Incstar Corp.. The 510(k) number is K915570.

When did GAMMA COAT ASSAY TESTOSTERONE RADIOIMMUNOASSAY KIT receive FDA 510(k) clearance?

GAMMA COAT ASSAY TESTOSTERONE RADIOIMMUNOASSAY KIT received FDA 510(k) clearance on 1992-01-27, under 510(k) number K915570.

Who is the listed applicant for GAMMA COAT ASSAY TESTOSTERONE RADIOIMMUNOASSAY KIT?

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

What is the FDA product code for GAMMA COAT ASSAY TESTOSTERONE RADIOIMMUNOASSAY KIT?

The FDA product code for GAMMA COAT ASSAY TESTOSTERONE RADIOIMMUNOASSAY KIT is 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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