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FDA 510(k)

'RAPID ONE' - PROPOXYPHENE TEST

K-Number: K030835 · 2003-05-22

ApplicantAmerican Bio Medica Corp.
Decision Date2003-05-22
Product CodeJXN
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

'RAPID ONE' - PROPOXYPHENE TEST is the device name listed in this FDA 510(k) record. The listed applicant is American Bio Medica Corp.. It received FDA 510(k) clearance on 2003-05-22 under 510(k) number K030835. 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 'RAPID ONE' - PROPOXYPHENE TEST?

'RAPID ONE' - PROPOXYPHENE TEST is a medical device that received FDA 510(k) clearance on 2003-05-22. The listed applicant is American Bio Medica Corp.. The 510(k) number is K030835.

When did 'RAPID ONE' - PROPOXYPHENE TEST receive FDA 510(k) clearance?

'RAPID ONE' - PROPOXYPHENE TEST received FDA 510(k) clearance on 2003-05-22, under 510(k) number K030835.

Who is the listed applicant for 'RAPID ONE' - PROPOXYPHENE TEST?

The FDA 510(k) record lists American Bio Medica Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 'RAPID ONE' - PROPOXYPHENE TEST?

The FDA product code for 'RAPID ONE' - PROPOXYPHENE TEST is JXN.

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K170222Rapid Tox Cup IIK073078RAPID TOX CUPK060760RAPIDONE-BUPRENORPHINE TESTK053422RAPIDONE-COCAINE-150 TESTK053359RAPIDTOXK041696RAPID READER

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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.K023795PROPOXYPHENE ENZYME IMMUNOASSAY, CATALOG #0120 (500 TEST KIT), #0121 (5000 TEST KIT)Lin-Zhi International, Inc.K022915INSTANT-VIEW PROPOXYPHENE (PPX) URINE TESTAlfa Scientific Designs, 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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