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)

U.S. DIAGNOSTICS ENZYMATIC TRIGLYCERIDE TEST

K-Number: K864231 · 1986-12-04

ApplicantU. S. Diagnostics, Inc.
Decision Date1986-12-04
Product CodeCDT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

U.S. DIAGNOSTICS ENZYMATIC TRIGLYCERIDE TEST is the device name listed in this FDA 510(k) record. The listed applicant is U. S. Diagnostics, Inc.. It received FDA 510(k) clearance on 1986-12-04 under 510(k) number K864231. 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 U.S. DIAGNOSTICS ENZYMATIC TRIGLYCERIDE TEST?

U.S. DIAGNOSTICS ENZYMATIC TRIGLYCERIDE TEST is a medical device that received FDA 510(k) clearance on 1986-12-04. The listed applicant is U. S. Diagnostics, Inc.. The 510(k) number is K864231.

When did U.S. DIAGNOSTICS ENZYMATIC TRIGLYCERIDE TEST receive FDA 510(k) clearance?

U.S. DIAGNOSTICS ENZYMATIC TRIGLYCERIDE TEST received FDA 510(k) clearance on 1986-12-04, under 510(k) number K864231.

Who is the listed applicant for U.S. DIAGNOSTICS ENZYMATIC TRIGLYCERIDE TEST?

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

What is the FDA product code for U.S. DIAGNOSTICS ENZYMATIC TRIGLYCERIDE TEST?

The FDA product code for U.S. DIAGNOSTICS ENZYMATIC TRIGLYCERIDE TEST 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 U. S. 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.

K110435EASYGLUCO PLUS BLOOD GLUCOSE MONITORING SYSTEMK082201G5 INFINITY BLODO GLUCOSE MONITORING SYSTEM WITH MODEL IGM, 0024AK061431EASYGLUCO, MODEL IGM-0002 G2K051651G4, MODEL IGM-0004K870596PROTHROMBIN TIME TESTK870686COAGULATION CONTROL, LEVEL II

View all 22 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.

↑