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FDA 510(k)

ABUSCREEN ONTRAK POS.REF.CONTROL FOR PHENCYCLIDINE

K-Number: K893860 · 1989-08-03

ApplicantRoche Diagnostic Systems, Inc.
Decision Date1989-08-03
Product CodeLAS
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

ABUSCREEN ONTRAK POS.REF.CONTROL FOR PHENCYCLIDINE 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 1989-08-03 under 510(k) number K893860. The device is classified under product code LAS. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ABUSCREEN ONTRAK POS.REF.CONTROL FOR PHENCYCLIDINE?

ABUSCREEN ONTRAK POS.REF.CONTROL FOR PHENCYCLIDINE is a medical device that received FDA 510(k) clearance on 1989-08-03. The listed applicant is Roche Diagnostic Systems, Inc.. The 510(k) number is K893860.

When did ABUSCREEN ONTRAK POS.REF.CONTROL FOR PHENCYCLIDINE receive FDA 510(k) clearance?

ABUSCREEN ONTRAK POS.REF.CONTROL FOR PHENCYCLIDINE received FDA 510(k) clearance on 1989-08-03, under 510(k) number K893860.

Who is the listed applicant for ABUSCREEN ONTRAK POS.REF.CONTROL FOR PHENCYCLIDINE?

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 ONTRAK POS.REF.CONTROL FOR PHENCYCLIDINE?

The FDA product code for ABUSCREEN ONTRAK POS.REF.CONTROL FOR PHENCYCLIDINE is LAS.

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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

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Related Devices (Code: LAS)

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.

K080459CHROMESYTEMS TOXICOLOGY CALIBRATORS AND CONTROLSChromsystems Instruments & Chemicals GmbHK072257MYCOPHENOLIC ACID CONTROL, LEVEL 1, 2, 3, 4, 4-LEVELMore DiagnosticsK062942QUANTIMETRIX NICOSURE COTININE URINE CONTROLQuantimetrix Corp.K051074MAS IMMUNOSUPPRESSANT CONTROLSMicrogenics Corp.K040411DRI OXYCODONE ASSAYMicrogenics Corp.K032842MICROGENICS CYCLOSPORINE CONTROL KITMicrogenics Corp.

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.

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