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FDA 510(k)

MODIFICATION TO ABUSCREEN ONLINE BARBITURATES

K-Number: K983698 · 1999-05-03

ApplicantRoche Diagnostic Systems, Inc.
Decision Date1999-05-03
Product CodeDIS
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO ABUSCREEN ONLINE BARBITURATES 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 1999-05-03 under 510(k) number K983698. The device is classified under product code DIS. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFICATION TO ABUSCREEN ONLINE BARBITURATES?

MODIFICATION TO ABUSCREEN ONLINE BARBITURATES is a medical device that received FDA 510(k) clearance on 1999-05-03. The listed applicant is Roche Diagnostic Systems, Inc.. The 510(k) number is K983698.

When did MODIFICATION TO ABUSCREEN ONLINE BARBITURATES receive FDA 510(k) clearance?

MODIFICATION TO ABUSCREEN ONLINE BARBITURATES received FDA 510(k) clearance on 1999-05-03, under 510(k) number K983698.

Who is the listed applicant for MODIFICATION TO ABUSCREEN ONLINE BARBITURATES?

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 MODIFICATION TO ABUSCREEN ONLINE BARBITURATES?

The FDA product code for MODIFICATION TO ABUSCREEN ONLINE BARBITURATES is DIS.

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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.

K983702MODIFICATION TO ABUSCREEN ONLINE FOR BENZOIDIAZEPINESK983704MODIFICATION TO ABUSCREEN ONLINE FOR PHENCYCLIDINEK983556ABUSCREEN ONLINE BENZ 300 CALIBRATORSK983555ABUSCREEN ONLINE BENZ 200 CALIBRATORSK983700MODIFICATION TO ABUSCREEN ONLINE FOR PROPOXYPHENEK983697MODIFICATION TO ABUSCREEN ONLINE COCAINE METABOLITE

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Related Devices (Code: DIS)

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.

K161714Immunalysis Barbiturates Urine Enzyme Immunoassay, Immunalysis Multi-Drug CalibratorsImmunalysis CorporationK092268RANDOX BARITURATES ASSAYRandox Laboratories, Ltd.K110515UCP DRUG SCREENING TEST CUPSUcp Biosciences, Inc.K070098QUICKSCREEN BARBITURATE 300 SCREENING TEST, MODELS 9019, 9018; MULTI DRUG SCREENING TEST, MODEL 9317T; CUP MULTI DRUG SCPhamatech, Inc.K070009AT HOME DRUG TEST MODELS, 9308T AND 9308XPhamatech, Inc.K062165VITROS CHEMISTRY PRODUCTS BARB REAGENT; CALIBRATOR KIT 26; FS CALIBRATOR 1; DAT PERFORMANCE VERIFIERSOrtho-Clinical Diagnostics

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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