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FDA 510(k)

TESTOSTERONE RADIOIMMUNOASSAY KIT 125I

K-Number: K780792 · 1978-06-13

ApplicantThe Upjohn Co.
Decision Date1978-06-13
Product CodeCDZ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

TESTOSTERONE RADIOIMMUNOASSAY KIT 125I is the device name listed in this FDA 510(k) record. The listed applicant is The Upjohn Co.. It received FDA 510(k) clearance on 1978-06-13 under 510(k) number K780792. 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 RADIOIMMUNOASSAY KIT 125I?

TESTOSTERONE RADIOIMMUNOASSAY KIT 125I is a medical device that received FDA 510(k) clearance on 1978-06-13. The listed applicant is The Upjohn Co.. The 510(k) number is K780792.

When did TESTOSTERONE RADIOIMMUNOASSAY KIT 125I receive FDA 510(k) clearance?

TESTOSTERONE RADIOIMMUNOASSAY KIT 125I received FDA 510(k) clearance on 1978-06-13, under 510(k) number K780792.

Who is the listed applicant for TESTOSTERONE RADIOIMMUNOASSAY KIT 125I?

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

What is the FDA product code for TESTOSTERONE RADIOIMMUNOASSAY KIT 125I?

The FDA product code for TESTOSTERONE RADIOIMMUNOASSAY KIT 125I is CDZ.

Related Clinical Trials

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Other records listing The Upjohn Co. 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.

K902004TROBICIN SUSCEPTIBILITY POWDERK900455ZEFAZONE SUSCEPTIBILITY POWDERK810853CK-TOTAL/CK-B (NAC) BIOLUMIN. ASSAY KITK782009RIA KIT, PROGESTERONEK760920CAT-A-KIT

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.

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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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