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FDA 510(k)

RAPIDSENSE DRUGS OF ABUSE METHAMPHETAMINE (MET) 1000 DEVICE, MODEL 900-0050

K-Number: K080455 · 2008-12-31

ApplicantQuantrx Biomedical Corporation
Decision Date2008-12-31
Product CodeLAF
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

RAPIDSENSE DRUGS OF ABUSE METHAMPHETAMINE (MET) 1000 DEVICE, MODEL 900-0050 is the device name listed in this FDA 510(k) record. The listed applicant is Quantrx Biomedical Corporation. It received FDA 510(k) clearance on 2008-12-31 under 510(k) number K080455. The device is classified under product code LAF. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RAPIDSENSE DRUGS OF ABUSE METHAMPHETAMINE (MET) 1000 DEVICE, MODEL 900-0050?

RAPIDSENSE DRUGS OF ABUSE METHAMPHETAMINE (MET) 1000 DEVICE, MODEL 900-0050 is a medical device that received FDA 510(k) clearance on 2008-12-31. The listed applicant is Quantrx Biomedical Corporation. The 510(k) number is K080455.

When did RAPIDSENSE DRUGS OF ABUSE METHAMPHETAMINE (MET) 1000 DEVICE, MODEL 900-0050 receive FDA 510(k) clearance?

RAPIDSENSE DRUGS OF ABUSE METHAMPHETAMINE (MET) 1000 DEVICE, MODEL 900-0050 received FDA 510(k) clearance on 2008-12-31, under 510(k) number K080455.

Who is the listed applicant for RAPIDSENSE DRUGS OF ABUSE METHAMPHETAMINE (MET) 1000 DEVICE, MODEL 900-0050?

The FDA 510(k) record lists Quantrx Biomedical Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RAPIDSENSE DRUGS OF ABUSE METHAMPHETAMINE (MET) 1000 DEVICE, MODEL 900-0050?

The FDA product code for RAPIDSENSE DRUGS OF ABUSE METHAMPHETAMINE (MET) 1000 DEVICE, MODEL 900-0050 is LAF.

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Other records listing Quantrx Biomedical Corporation 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.

K080436RAPIDSENSE DRUGS OF ABUSE COCAINE (COC) 300 DEVICE, MODEL 900-0052K080431RAPIDSENSE DRUGS OF ABUSE PHENCYCLIDINE (PCP) 25 DEVICE WITH MODELS 900-0054K070484QUANTRX FEMALE FERTILITY TEST

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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