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)

FASTPACK TESTO IMMUNOASSAY

K-Number: K101388 · 2011-02-18

ApplicantQualigen, Inc.
Decision Date2011-02-18
Product CodeCDZ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

FASTPACK TESTO IMMUNOASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Qualigen, Inc.. It received FDA 510(k) clearance on 2011-02-18 under 510(k) number K101388. 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 FASTPACK TESTO IMMUNOASSAY?

FASTPACK TESTO IMMUNOASSAY is a medical device that received FDA 510(k) clearance on 2011-02-18. The listed applicant is Qualigen, Inc.. The 510(k) number is K101388.

When did FASTPACK TESTO IMMUNOASSAY receive FDA 510(k) clearance?

FASTPACK TESTO IMMUNOASSAY received FDA 510(k) clearance on 2011-02-18, under 510(k) number K101388.

Who is the listed applicant for FASTPACK TESTO IMMUNOASSAY?

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

What is the FDA product code for FASTPACK TESTO IMMUNOASSAY?

The FDA product code for FASTPACK TESTO 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 Qualigen, 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.

K182521FastPack IP Sex Hormone Binding Globulin ImmunoassayK123983FASTPACK VITAMIN D; IMMUNOASSAY, CALIBRATORS, CONTROLS, VERIFIERSK123725FASTPACK CONTROL KITK101390FASTPACK TSH IMMUNOASSAYK072264FASTPACK HCG IMMUNOASSAYK062957FASTPACK TOTAL PSA METHOD VERIFICATION KIT

View all 14 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.

↑