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)

ECLIPSE ICA TRIGLYCERIDES

K-Number: K905601 · 1991-01-17

ApplicantBiotope, Inc.
Decision Date1991-01-17
Product CodeCDT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ECLIPSE ICA TRIGLYCERIDES is the device name listed in this FDA 510(k) record. The listed applicant is Biotope, Inc.. It received FDA 510(k) clearance on 1991-01-17 under 510(k) number K905601. The device is classified under product code CDT. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ECLIPSE ICA TRIGLYCERIDES?

ECLIPSE ICA TRIGLYCERIDES is a medical device that received FDA 510(k) clearance on 1991-01-17. The listed applicant is Biotope, Inc.. The 510(k) number is K905601.

When did ECLIPSE ICA TRIGLYCERIDES receive FDA 510(k) clearance?

ECLIPSE ICA TRIGLYCERIDES received FDA 510(k) clearance on 1991-01-17, under 510(k) number K905601.

Who is the listed applicant for ECLIPSE ICA TRIGLYCERIDES?

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

What is the FDA product code for ECLIPSE ICA TRIGLYCERIDES?

The FDA product code for ECLIPSE ICA TRIGLYCERIDES is CDT.

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 Biotope, 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.

K905145ECLIPSE ICA CHOLESTEROLK910302ECLIPSE ICA ANALYZERK910256ECLIPSE ICA TSHK905719ECLIPSE ICA DIGOXINK905602ECLIPSE ICA BUNK905144ECLIPSE ICA GLUCOSE

View all 7 devices →

Related Devices (Code: CDT)

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.

K133067ADVIA CHEMISTRY TRIGLYCERIDES_2 (TRIG_2) REAGENTSiemens Healthcare Diagnostics, Inc.K130332VITROS CHEMISTRY PRODUCTS TRIG SLIDESOrtho-Clinical Diagnostics, Inc.K113830VANTERA CLINICAL ANALYZERLiposcienceK102993ELITECH CLINICAL SYSTEMS TRIGLYCERIDES SL, ELITECH CLINICAL SYSTEMS CHOLESTEROL SLSeppim S.A.S.K063804OLYMPUS TRIGLYCERIDE TEST SYSTEMOlympus America, Inc.K043546DIMENSION RXL MAX WITH STREAMLAB ANALYTICAL WORKCELL AND SAMPLE TRANSFER MODULEDade Behring, 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.

↑