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FDA 510(k)

'RAPIDONE'-METHADONE TEST

K-Number: K012164 · 2001-11-20

ApplicantAmerican Bio Medica Corp.
Decision Date2001-11-20
Product CodeDJR
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

'RAPIDONE'-METHADONE 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 2001-11-20 under 510(k) number K012164. The device is classified under product code DJR. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 'RAPIDONE'-METHADONE TEST?

'RAPIDONE'-METHADONE TEST is a medical device that received FDA 510(k) clearance on 2001-11-20. The listed applicant is American Bio Medica Corp.. The 510(k) number is K012164.

When did 'RAPIDONE'-METHADONE TEST receive FDA 510(k) clearance?

'RAPIDONE'-METHADONE TEST received FDA 510(k) clearance on 2001-11-20, under 510(k) number K012164.

Who is the listed applicant for 'RAPIDONE'-METHADONE 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 'RAPIDONE'-METHADONE TEST?

The FDA product code for 'RAPIDONE'-METHADONE TEST is DJR.

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Other records listing American Bio Medica Corp. 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.

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

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Related Devices (Code: DJR)

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.

K192433LZI Methadone II Enzyme ImmunoassayLin-Zhi International, Inc.K182779ARK EDDP AssayArk Diagnostics, Inc.K170416LZI Methadone Metabolite Enzyme Immunoassay, LZI Methadone Metabolite (100 and 300) CalibratorsLin-Zhi International, Inc.K160793First Sign Drug of Abuse Dip Card Test (MDMA, EDDP, Nortriptyline), First Sign Drug of Abuse Cup Test (MDMA, EDDP, Nortriptyline)W.H.P.M., Inc.K131232WONDFO METHADONE URINE TEST (MTD 200), WONDOFO MORPHINE URINE TEST (MOP 100)Guangzhou Wondfo Biotech Co., Ltd.K092272RANDOX METHADONE ASSAYRandox Laboratories, 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.

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