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FDA 510(k)

I TESTOTERONE

K-Number: K790007 · 1979-02-26

ApplicantCambridge Nuclear Corp.
Decision Date1979-02-26
Product CodeCDZ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

I TESTOTERONE is the device name listed in this FDA 510(k) record. The listed applicant is Cambridge Nuclear Corp.. It received FDA 510(k) clearance on 1979-02-26 under 510(k) number K790007. 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 I TESTOTERONE?

I TESTOTERONE is a medical device that received FDA 510(k) clearance on 1979-02-26. The listed applicant is Cambridge Nuclear Corp.. The 510(k) number is K790007.

When did I TESTOTERONE receive FDA 510(k) clearance?

I TESTOTERONE received FDA 510(k) clearance on 1979-02-26, under 510(k) number K790007.

Who is the listed applicant for I TESTOTERONE?

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

What is the FDA product code for I TESTOTERONE?

The FDA product code for I TESTOTERONE is CDZ.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Other records listing Cambridge Nuclear Corp. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K811380ESTRIOL KITK810804PROGESTERONE KITK790362I BRADYKININ & ANTI-BRADYKININ ANTISERUMK790008I ESTRIOL

Related Devices (Code: CDZ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252728IDS-iSYS Total TestosteroneImmunodiagnostic Systems LimitedK240865IDS-iSYS Free TestosteroneImmunodiagnostic Systems LimitedK233480Access SHBGBeckman Coulter, Inc.K223405Access TestosteroneBeckman Coulter, Inc.K211685Elecsys Testosterone IIRoche DiagnosticsK201908LIAISON Testosterone xtDiaSorin, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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