FDA 510(k)

MODIFICATION TO INSTANT-VIEW METHAMPHETAMINE (METH 1000) URINE TEST (DIP STRIP)

K-Number: K003845 · 2001-05-29

Decision Date2001-05-29

Product CodeLAF

Advisory CommitteeTX

DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO INSTANT-VIEW METHAMPHETAMINE (METH 1000) URINE TEST (DIP STRIP) is the device name listed in this FDA 510(k) record. The listed applicant is Alfa Scientific Designs, Inc.. It received FDA 510(k) clearance on 2001-05-29 under 510(k) number K003845. 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 MODIFICATION TO INSTANT-VIEW METHAMPHETAMINE (METH 1000) URINE TEST (DIP STRIP)?

MODIFICATION TO INSTANT-VIEW METHAMPHETAMINE (METH 1000) URINE TEST (DIP STRIP) is a medical device that received FDA 510(k) clearance on 2001-05-29. The listed applicant is Alfa Scientific Designs, Inc.. The 510(k) number is K003845.

When did MODIFICATION TO INSTANT-VIEW METHAMPHETAMINE (METH 1000) URINE TEST (DIP STRIP) receive FDA 510(k) clearance?

MODIFICATION TO INSTANT-VIEW METHAMPHETAMINE (METH 1000) URINE TEST (DIP STRIP) received FDA 510(k) clearance on 2001-05-29, under 510(k) number K003845.

Who is the listed applicant for MODIFICATION TO INSTANT-VIEW METHAMPHETAMINE (METH 1000) URINE TEST (DIP STRIP)?

The FDA 510(k) record lists Alfa Scientific Designs, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODIFICATION TO INSTANT-VIEW METHAMPHETAMINE (METH 1000) URINE TEST (DIP STRIP)?

The FDA product code for MODIFICATION TO INSTANT-VIEW METHAMPHETAMINE (METH 1000) URINE TEST (DIP STRIP) 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.