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)

SRI TESTOSTERONE ENZYME IMMUNOASSAY

K-Number: K915164 · 1992-03-02

ApplicantSerono-Baker Diagnostics, Inc.
Decision Date1992-03-02
Product CodeCDZ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SRI TESTOSTERONE ENZYME IMMUNOASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Serono-Baker Diagnostics, Inc.. It received FDA 510(k) clearance on 1992-03-02 under 510(k) number K915164. 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 SRI TESTOSTERONE ENZYME IMMUNOASSAY?

SRI TESTOSTERONE ENZYME IMMUNOASSAY is a medical device that received FDA 510(k) clearance on 1992-03-02. The listed applicant is Serono-Baker Diagnostics, Inc.. The 510(k) number is K915164.

When did SRI TESTOSTERONE ENZYME IMMUNOASSAY receive FDA 510(k) clearance?

SRI TESTOSTERONE ENZYME IMMUNOASSAY received FDA 510(k) clearance on 1992-03-02, under 510(k) number K915164.

Who is the listed applicant for SRI TESTOSTERONE ENZYME IMMUNOASSAY?

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

What is the FDA product code for SRI TESTOSTERONE ENZYME IMMUNOASSAY?

The FDA product code for SRI TESTOSTERONE ENZYME IMMUNOASSAY 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 Serono-Baker Diagnostics, 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.

K924257TESTOSTERONE SEROZYME(TM) ENZYME IMMUNOASSAYK914886SRI(TM) CORTISOL ENZYME IMMUNOASSAY(MAG SOL PHASE)K915602SRI DIGOXIN ENZYME IMMUNOASSAYK912937SR1 FREE T4 ENZYME IMMUNOASSAYK914462SRI PROGESTERONE ENZYME IMMUNOASSAY(MAG SOLD PHAS)K911912SR1 T3 UPTAKE ENZYME IMMUNOASSAY(MAG SOLID-PHASE)

View all 23 devices →

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.

↑