Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

DRG AURICA ELISA TESTOSTERONE KIT

K-Number: K000043 · 2000-04-17

ApplicantDrg Intl., Inc.
Decision Date2000-04-17
Product CodeCDZ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DRG AURICA ELISA TESTOSTERONE KIT is the device name listed in this FDA 510(k) record. The listed applicant is Drg Intl., Inc.. It received FDA 510(k) clearance on 2000-04-17 under 510(k) number K000043. 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 DRG AURICA ELISA TESTOSTERONE KIT?

DRG AURICA ELISA TESTOSTERONE KIT is a medical device that received FDA 510(k) clearance on 2000-04-17. The listed applicant is Drg Intl., Inc.. The 510(k) number is K000043.

When did DRG AURICA ELISA TESTOSTERONE KIT receive FDA 510(k) clearance?

DRG AURICA ELISA TESTOSTERONE KIT received FDA 510(k) clearance on 2000-04-17, under 510(k) number K000043.

Who is the listed applicant for DRG AURICA ELISA TESTOSTERONE KIT?

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

What is the FDA product code for DRG AURICA ELISA TESTOSTERONE KIT?

The FDA product code for DRG AURICA ELISA TESTOSTERONE KIT 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Drg Intl., 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.

K062534ENZYME IMMUNOASSAY FOR THE DETECTION OF SALIVARY 17-A-HYDROXYPROGESTERONEK052649DRG SLV TESTOSTERONE ELISA TESTK051733ENZYME IMMUNOASSAY FOR THE DETECTION OF SALIVARY CORTISOL

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.

↑