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)

ABUSCREEN RADIOIMMUNOASSAY FOR AMPHETAMINE-HIGH SP

K-Number: K854009 · 1985-10-15

ApplicantRoche Diagnostic Systems, Inc.
Decision Date1985-10-15
Product CodeDJP
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

ABUSCREEN RADIOIMMUNOASSAY FOR AMPHETAMINE-HIGH SP is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostic Systems, Inc.. It received FDA 510(k) clearance on 1985-10-15 under 510(k) number K854009. The device is classified under product code DJP. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ABUSCREEN RADIOIMMUNOASSAY FOR AMPHETAMINE-HIGH SP?

ABUSCREEN RADIOIMMUNOASSAY FOR AMPHETAMINE-HIGH SP is a medical device that received FDA 510(k) clearance on 1985-10-15. The listed applicant is Roche Diagnostic Systems, Inc.. The 510(k) number is K854009.

When did ABUSCREEN RADIOIMMUNOASSAY FOR AMPHETAMINE-HIGH SP receive FDA 510(k) clearance?

ABUSCREEN RADIOIMMUNOASSAY FOR AMPHETAMINE-HIGH SP received FDA 510(k) clearance on 1985-10-15, under 510(k) number K854009.

Who is the listed applicant for ABUSCREEN RADIOIMMUNOASSAY FOR AMPHETAMINE-HIGH SP?

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

What is the FDA product code for ABUSCREEN RADIOIMMUNOASSAY FOR AMPHETAMINE-HIGH SP?

The FDA product code for ABUSCREEN RADIOIMMUNOASSAY FOR AMPHETAMINE-HIGH SP is DJP.

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 Roche Diagnostic Systems, 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.

K983698MODIFICATION TO ABUSCREEN ONLINE BARBITURATESK983702MODIFICATION TO ABUSCREEN ONLINE FOR BENZOIDIAZEPINESK983704MODIFICATION TO ABUSCREEN ONLINE FOR PHENCYCLIDINEK983556ABUSCREEN ONLINE BENZ 300 CALIBRATORSK983555ABUSCREEN ONLINE BENZ 200 CALIBRATORSK983700MODIFICATION TO ABUSCREEN ONLINE FOR PROPOXYPHENE

View all 296 devices →

Related Devices (Code: DJP)

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.

K960526PRIMIDONE EIA TESTDiagnostic Reagents, Inc.K913866URINE AMPHETAMINE DIRECT RIA KIT (I-125)Immunalysis CorporationK912755ABUSCREEN RADIOIMMUNOASSAY FOR AMPHETAMINERoche Diagnostic Systems, Inc.K882228REVISED DOUBLE ANTIBODY AMPHETAMINEDiagnostic Products Corp.K881817ABUSCREEN(R) ONTRAK(TM) FOR AMPHETAMINESRoche Diagnostic Systems, Inc.K830482ABUSCREEN RADIOIMMUNOASSAY-AMPHETAMINEHoffmann-La Roche, 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.

↑