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 ONLINE(R) CALIBRATORS

K-Number: K946000 · 1995-01-25

ApplicantRoche Diagnostic Systems, Inc.
Decision Date1995-01-25
Product CodeDKJ
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

ABUSCREEN ONLINE(R) CALIBRATORS 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 1995-01-25 under 510(k) number K946000. The device is classified under product code DKJ. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ABUSCREEN ONLINE(R) CALIBRATORS?

ABUSCREEN ONLINE(R) CALIBRATORS is a medical device that received FDA 510(k) clearance on 1995-01-25. The listed applicant is Roche Diagnostic Systems, Inc.. The 510(k) number is K946000.

When did ABUSCREEN ONLINE(R) CALIBRATORS receive FDA 510(k) clearance?

ABUSCREEN ONLINE(R) CALIBRATORS received FDA 510(k) clearance on 1995-01-25, under 510(k) number K946000.

Who is the listed applicant for ABUSCREEN ONLINE(R) CALIBRATORS?

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 ONLINE(R) CALIBRATORS?

The FDA product code for ABUSCREEN ONLINE(R) CALIBRATORS is DKJ.

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: DKJ)

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.

K093939ADVIA CHEMISTRY SALICYLATE REAGENTSiemens Healthcare DiagnosticsK042329SALICYLATE-SL ASSAYDiagnostic Chemicals , Ltd.K020794SALICYLATE ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEMBayer Diagnostics Corp.K014173SYNCHRON SYSTEMS SALICYLATE REAGENT AND CALIBRATORBeckman Coulter, Inc.K011878EMIT (R) TOX SALICYLIC ASSAY, MODEL 7SO19UL, EMIT (R) TOX SALICYLIC ACID CALIBRATORS, MODEL 7S109ULSyva Co.K981872SALICYLATE-SL ASSAY CATALOGUE NUMBER 511-20,511-40Diagnostic Chemicals , Ltd.

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.

↑