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FDA 510(k)

ACON ONE STEP DRUG SCREEN TEST CARD

K-Number: K020771 · 2002-05-15

ApplicantACON Laboratories, Inc.
Decision Date2002-05-15
Product CodeDIO
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

ACON ONE STEP DRUG SCREEN TEST CARD 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 2002-05-15 under 510(k) number K020771. The device is classified under product code DIO. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACON ONE STEP DRUG SCREEN TEST CARD?

ACON ONE STEP DRUG SCREEN TEST CARD is a medical device that received FDA 510(k) clearance on 2002-05-15. The listed applicant is ACON Laboratories, Inc.. The 510(k) number is K020771.

When did ACON ONE STEP DRUG SCREEN TEST CARD receive FDA 510(k) clearance?

ACON ONE STEP DRUG SCREEN TEST CARD received FDA 510(k) clearance on 2002-05-15, under 510(k) number K020771.

Who is the listed applicant for ACON ONE STEP DRUG SCREEN TEST CARD?

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 ONE STEP DRUG SCREEN TEST CARD?

The FDA product code for ACON ONE STEP DRUG SCREEN TEST CARD is DIO.

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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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