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FDA 510(k)

ACON AMP 300 ONE STEP AMPHETAMINE TEST STRIP AND DEVICE

K-Number: K041822 · 2004-09-16

ApplicantACON Laboratories, Inc.
Decision Date2004-09-16
Product CodeDKZ
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

ACON AMP 300 ONE STEP AMPHETAMINE TEST STRIP AND DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is ACON Laboratories, Inc.. It received FDA 510(k) clearance on 2004-09-16 under 510(k) number K041822. The device is classified under product code DKZ. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACON AMP 300 ONE STEP AMPHETAMINE TEST STRIP AND DEVICE?

ACON AMP 300 ONE STEP AMPHETAMINE TEST STRIP AND DEVICE is a medical device that received FDA 510(k) clearance on 2004-09-16. The listed applicant is ACON Laboratories, Inc.. The 510(k) number is K041822.

When did ACON AMP 300 ONE STEP AMPHETAMINE TEST STRIP AND DEVICE receive FDA 510(k) clearance?

ACON AMP 300 ONE STEP AMPHETAMINE TEST STRIP AND DEVICE received FDA 510(k) clearance on 2004-09-16, under 510(k) number K041822.

Who is the listed applicant for ACON AMP 300 ONE STEP AMPHETAMINE TEST STRIP AND DEVICE?

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

What is the FDA product code for ACON AMP 300 ONE STEP AMPHETAMINE TEST STRIP AND DEVICE?

The FDA product code for ACON AMP 300 ONE STEP AMPHETAMINE TEST STRIP AND DEVICE is DKZ.

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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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