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FDA 510(k)

ACTIVE FREE TESTOSTERONE RIA

K-Number: K952281 · 1995-07-17

ApplicantDiagnostic Systems Laboratories, Inc.
Decision Date1995-07-17
Product CodeCDZ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ACTIVE FREE TESTOSTERONE RIA is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostic Systems Laboratories, Inc.. It received FDA 510(k) clearance on 1995-07-17 under 510(k) number K952281. 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 ACTIVE FREE TESTOSTERONE RIA?

ACTIVE FREE TESTOSTERONE RIA is a medical device that received FDA 510(k) clearance on 1995-07-17. The listed applicant is Diagnostic Systems Laboratories, Inc.. The 510(k) number is K952281.

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

ACTIVE FREE TESTOSTERONE RIA received FDA 510(k) clearance on 1995-07-17, under 510(k) number K952281.

Who is the listed applicant for ACTIVE FREE TESTOSTERONE RIA?

The FDA 510(k) record lists Diagnostic Systems Laboratories, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ACTIVE FREE TESTOSTERONE RIA?

The FDA product code for ACTIVE FREE TESTOSTERONE RIA is CDZ.

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Other records listing Diagnostic Systems Laboratories, 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.

K061758ACTIVE RENIN IRMAK020945AXSYM INTACT PTH, MODEL 2G06K020128ACTIVE FREE BETA-HCG ELISA, MODEL DSL-10-8500K002128ACTIVE INHIBIN-A ELISA, MODEL DSL-10-28100K001086FREE TESTOSTERONE ENZYME IMMUNOASSAY, MODEL DSL-10-4900K990138DSL ACTIVE AFP ELISA, MODEL DSL-10-8400

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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.

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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