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FDA 510(k)

MODIFICATION TO ABUSCREEN ONLINE FOR PROPOXYPHENE

K-Number: K983700 · 1998-12-11

ApplicantRoche Diagnostic Systems, Inc.
Decision Date1998-12-11
Product CodeJXN
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO ABUSCREEN ONLINE FOR PROPOXYPHENE 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 1998-12-11 under 510(k) number K983700. The device is classified under product code JXN. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFICATION TO ABUSCREEN ONLINE FOR PROPOXYPHENE?

MODIFICATION TO ABUSCREEN ONLINE FOR PROPOXYPHENE is a medical device that received FDA 510(k) clearance on 1998-12-11. The listed applicant is Roche Diagnostic Systems, Inc.. The 510(k) number is K983700.

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

MODIFICATION TO ABUSCREEN ONLINE FOR PROPOXYPHENE received FDA 510(k) clearance on 1998-12-11, under 510(k) number K983700.

Who is the listed applicant for MODIFICATION TO ABUSCREEN ONLINE FOR PROPOXYPHENE?

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 FOR PROPOXYPHENE?

The FDA product code for MODIFICATION TO ABUSCREEN ONLINE FOR PROPOXYPHENE is JXN.

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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 CALIBRATORSK983697MODIFICATION TO ABUSCREEN ONLINE COCAINE METABOLITE

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Related Devices (Code: JXN)

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.

K122752FASTECT II PPX DRUG SCREEN DIPSTICK, FASTECT II DRUG SCREEN DIPSTICK, QUICKTOX DRUG SCREEN DIPCARDBranan Medical Corp.K111363PPX REAGENT, PPX CALIBRATORS, PPX QC MATERIALMedica Corp.K043303ONLINE DAT PROPOXYPHENE PLUSRoche Diagnostics Corp.K040445ACON PPX ONE STEP PROPOXYPHENE TEST STRIP AND ACON PPX STEP PROPOXYPHENE TEST DEVICEACON Laboratories, Inc.K030835'RAPID ONE' - PROPOXYPHENE TESTAmerican Bio Medica Corp.K023795PROPOXYPHENE ENZYME IMMUNOASSAY, CATALOG #0120 (500 TEST KIT), #0121 (5000 TEST KIT)Lin-Zhi International, 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.

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