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FDA 510(k)

DIRECT TESTOSTERONE RIA

K-Number: K811536 · 1981-06-18

ApplicantImmuchem Corp.
Decision Date1981-06-18
Product CodeCDZ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DIRECT TESTOSTERONE RIA is the device name listed in this FDA 510(k) record. The listed applicant is Immuchem Corp.. It received FDA 510(k) clearance on 1981-06-18 under 510(k) number K811536. 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 DIRECT TESTOSTERONE RIA?

DIRECT TESTOSTERONE RIA is a medical device that received FDA 510(k) clearance on 1981-06-18. The listed applicant is Immuchem Corp.. The 510(k) number is K811536.

When did DIRECT TESTOSTERONE RIA receive FDA 510(k) clearance?

DIRECT TESTOSTERONE RIA received FDA 510(k) clearance on 1981-06-18, under 510(k) number K811536.

Who is the listed applicant for DIRECT TESTOSTERONE RIA?

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

What is the FDA product code for DIRECT TESTOSTERONE RIA?

The FDA product code for DIRECT TESTOSTERONE RIA is CDZ.

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Other records listing Immuchem 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.

K883726THYROID STIMULATING HORMONE (HTSH) IRMA NEONATALK871317FOLLICLE STIMULATING HORMONE (HFSH)K871542HPROLACTIN KITK865071THYROID STIMULATING HORMONE (TSH IRMA) RIA KITK864144LUTEINIZING HORMONE (LH-IRMA) RIA KITK860559ANDROSTENEDIONE 125I KIT BY RIA

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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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