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FDA 510(k)

TESTOSTERONE BY ENZYMEIMMUNOASSAY (EIA)

K-Number: K014120 · 2002-02-08

ApplicantDiagnostics Biochem Canada, Inc.
Decision Date2002-02-08
Product CodeCDZ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

TESTOSTERONE BY ENZYMEIMMUNOASSAY (EIA) is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostics Biochem Canada, Inc.. It received FDA 510(k) clearance on 2002-02-08 under 510(k) number K014120. 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 BY ENZYMEIMMUNOASSAY (EIA)?

TESTOSTERONE BY ENZYMEIMMUNOASSAY (EIA) is a medical device that received FDA 510(k) clearance on 2002-02-08. The listed applicant is Diagnostics Biochem Canada, Inc.. The 510(k) number is K014120.

When did TESTOSTERONE BY ENZYMEIMMUNOASSAY (EIA) receive FDA 510(k) clearance?

TESTOSTERONE BY ENZYMEIMMUNOASSAY (EIA) received FDA 510(k) clearance on 2002-02-08, under 510(k) number K014120.

Who is the listed applicant for TESTOSTERONE BY ENZYMEIMMUNOASSAY (EIA)?

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

What is the FDA product code for TESTOSTERONE BY ENZYMEIMMUNOASSAY (EIA)?

The FDA product code for TESTOSTERONE BY ENZYMEIMMUNOASSAY (EIA) is CDZ.

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Other records listing Diagnostics Biochem Canada, Inc. 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.

K030730FREE TESTOSTERONE ENZYMEIMMUNOASSAY (EIA) KITK864966ESTRONE ANALYSIS PRODUCTS RADIOIMMUNOASSAY ESTRONEK832297HYDROXYPROGESTERONE-17K801729ANDROSTENEDIONE RADIOIMMUNOASSAY KITK781310HUMAN CHORIONIC GONADO.-BETA RIA 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.

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

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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