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)

DU PONT PHENYTOIN ASSAY AND CALIBRATOR

K-Number: K863888 · 1986-11-05

ApplicantE.I. Dupont DE Nemours & Co., Inc.
Decision Date1986-11-05
Product CodeDIR
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

DU PONT PHENYTOIN ASSAY AND CALIBRATOR is the device name listed in this FDA 510(k) record. The listed applicant is E.I. Dupont DE Nemours & Co., Inc.. It received FDA 510(k) clearance on 1986-11-05 under 510(k) number K863888. The device is classified under product code DIR. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DU PONT PHENYTOIN ASSAY AND CALIBRATOR?

DU PONT PHENYTOIN ASSAY AND CALIBRATOR is a medical device that received FDA 510(k) clearance on 1986-11-05. The listed applicant is E.I. Dupont DE Nemours & Co., Inc.. The 510(k) number is K863888.

When did DU PONT PHENYTOIN ASSAY AND CALIBRATOR receive FDA 510(k) clearance?

DU PONT PHENYTOIN ASSAY AND CALIBRATOR received FDA 510(k) clearance on 1986-11-05, under 510(k) number K863888.

Who is the listed applicant for DU PONT PHENYTOIN ASSAY AND CALIBRATOR?

The FDA 510(k) record lists E.I. Dupont DE Nemours & Co., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DU PONT PHENYTOIN ASSAY AND CALIBRATOR?

The FDA product code for DU PONT PHENYTOIN ASSAY AND CALIBRATOR is DIR.

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 E.I. Dupont DE Nemours & Co., 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.

K951851ALLIANCE CYTOMEGALOVIRUS IMMEDIATE EARLY ANTIGEN DIRECT IMMUNOFLUORESCENCE ASSAYK953724CRONEX RADIATION THERAPY CASSETTEK953725CRONEX RADIATION THERAPY VERIFICATION CASSETTEK951441DUPONT ACA DIGOXIN (DGN A) METHODK950137URINE BARBITURATES SCREEN FLEX(TM) REAGENT CARTRIDGEK950136URINE OPIATES SCREEN FLEX(TM) REAGENT CARTRIDGE

View all 253 devices →

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.

↑