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)

DART PHENOBARBITAL ASSAY SYSTEM

K-Number: K864612 · 1987-01-13

ApplicantCoulter Electronics, Inc.
Decision Date1987-01-13
Product CodeLFN
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

DART PHENOBARBITAL ASSAY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Coulter Electronics, Inc.. It received FDA 510(k) clearance on 1987-01-13 under 510(k) number K864612. The device is classified under product code LFN. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DART PHENOBARBITAL ASSAY SYSTEM?

DART PHENOBARBITAL ASSAY SYSTEM is a medical device that received FDA 510(k) clearance on 1987-01-13. The listed applicant is Coulter Electronics, Inc.. The 510(k) number is K864612.

When did DART PHENOBARBITAL ASSAY SYSTEM receive FDA 510(k) clearance?

DART PHENOBARBITAL ASSAY SYSTEM received FDA 510(k) clearance on 1987-01-13, under 510(k) number K864612.

Who is the listed applicant for DART PHENOBARBITAL ASSAY SYSTEM?

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

What is the FDA product code for DART PHENOBARBITAL ASSAY SYSTEM?

The FDA product code for DART PHENOBARBITAL ASSAY SYSTEM is LFN.

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 Coulter Electronics, 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.

K923951CD8 CYTOSPHERES KITK930119COULTER RETIC-C CELL CONTROLK921279CD4 CYTOSPHERES KITK923530COULTER MULTI-Q-PREPK922181COULTER MH009K922704COULTER MAXM W/ AUTOLOADER

View all 101 devices →

Related Devices (Code: LFN)

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.

K934388QMS PHENOBARBITALSeradyn, Inc.K860304DUPONT PHENOBARBITAL ASSAYE.I. Dupont DE Nemours & Co., Inc.K860303DUPONT PHENOBARBITAL CALIBRATORE.I. Dupont DE Nemours & Co., Inc.K821543IPA FOR DETECTION OF PHENOBARBITALElectro-Nucleonics Laboratories, 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.

↑