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FDA 510(k)

ACON BAR II ONE STEP BARBITURATES TEST STRIP & DEVICE

K-Number: K050593 · 2005-05-06

ApplicantACON Laboratories, Inc.
Decision Date2005-05-06
Product CodeDIS
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

ACON BAR II ONE STEP BARBITURATES TEST STRIP & 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 2005-05-06 under 510(k) number K050593. The device is classified under product code DIS. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACON BAR II ONE STEP BARBITURATES TEST STRIP & DEVICE?

ACON BAR II ONE STEP BARBITURATES TEST STRIP & DEVICE is a medical device that received FDA 510(k) clearance on 2005-05-06. The listed applicant is ACON Laboratories, Inc.. The 510(k) number is K050593.

When did ACON BAR II ONE STEP BARBITURATES TEST STRIP & DEVICE receive FDA 510(k) clearance?

ACON BAR II ONE STEP BARBITURATES TEST STRIP & DEVICE received FDA 510(k) clearance on 2005-05-06, under 510(k) number K050593.

Who is the listed applicant for ACON BAR II ONE STEP BARBITURATES TEST STRIP & 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 BAR II ONE STEP BARBITURATES TEST STRIP & DEVICE?

The FDA product code for ACON BAR II ONE STEP BARBITURATES TEST STRIP & DEVICE is DIS.

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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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