FDA 510(k)

QUICKSCREEN METHAMPHETAMINE TEST, MODELS 9045, 9046, QUICKSCREEN PRO MULTI DRUG SCREENING TEST, MODEL 9225

K-Number: K000447 · 2000-03-07

Decision Date2000-03-07

Product CodeLAF

Advisory CommitteeTX

DecisionSubstantially Equivalent

Device Summary

QUICKSCREEN METHAMPHETAMINE TEST, MODELS 9045, 9046, QUICKSCREEN PRO MULTI DRUG SCREENING TEST, MODEL 9225 is the device name listed in this FDA 510(k) record. The listed applicant is Phamatech. It received FDA 510(k) clearance on 2000-03-07 under 510(k) number K000447. 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 QUICKSCREEN METHAMPHETAMINE TEST, MODELS 9045, 9046, QUICKSCREEN PRO MULTI DRUG SCREENING TEST, MODEL 9225?

QUICKSCREEN METHAMPHETAMINE TEST, MODELS 9045, 9046, QUICKSCREEN PRO MULTI DRUG SCREENING TEST, MODEL 9225 is a medical device that received FDA 510(k) clearance on 2000-03-07. The listed applicant is Phamatech. The 510(k) number is K000447.

When did QUICKSCREEN METHAMPHETAMINE TEST, MODELS 9045, 9046, QUICKSCREEN PRO MULTI DRUG SCREENING TEST, MODEL 9225 receive FDA 510(k) clearance?

QUICKSCREEN METHAMPHETAMINE TEST, MODELS 9045, 9046, QUICKSCREEN PRO MULTI DRUG SCREENING TEST, MODEL 9225 received FDA 510(k) clearance on 2000-03-07, under 510(k) number K000447.

Who is the listed applicant for QUICKSCREEN METHAMPHETAMINE TEST, MODELS 9045, 9046, QUICKSCREEN PRO MULTI DRUG SCREENING TEST, MODEL 9225?

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

What is the FDA product code for QUICKSCREEN METHAMPHETAMINE TEST, MODELS 9045, 9046, QUICKSCREEN PRO MULTI DRUG SCREENING TEST, MODEL 9225?

The FDA product code for QUICKSCREEN METHAMPHETAMINE TEST, MODELS 9045, 9046, QUICKSCREEN PRO MULTI DRUG SCREENING TEST, MODEL 9225 is LAF.

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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.