FDA 510(k)

FASTECT II BUP DRUG SCREEN DIPSTICK AND QUICKTOX BUP DRUG SCREEN DIPCARD

K-Number: K082508 · 2008-11-21

Decision Date2008-11-21

Product CodeDJG

Advisory CommitteeTX

DecisionSubstantially Equivalent

Device Summary

FASTECT II BUP DRUG SCREEN DIPSTICK AND QUICKTOX BUP DRUG SCREEN DIPCARD is the device name listed in this FDA 510(k) record. The listed applicant is Branan Medical Corporation. It received FDA 510(k) clearance on 2008-11-21 under 510(k) number K082508. The device is classified under product code DJG. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FASTECT II BUP DRUG SCREEN DIPSTICK AND QUICKTOX BUP DRUG SCREEN DIPCARD?

FASTECT II BUP DRUG SCREEN DIPSTICK AND QUICKTOX BUP DRUG SCREEN DIPCARD is a medical device that received FDA 510(k) clearance on 2008-11-21. The listed applicant is Branan Medical Corporation. The 510(k) number is K082508.

When did FASTECT II BUP DRUG SCREEN DIPSTICK AND QUICKTOX BUP DRUG SCREEN DIPCARD receive FDA 510(k) clearance?

FASTECT II BUP DRUG SCREEN DIPSTICK AND QUICKTOX BUP DRUG SCREEN DIPCARD received FDA 510(k) clearance on 2008-11-21, under 510(k) number K082508.

Who is the listed applicant for FASTECT II BUP DRUG SCREEN DIPSTICK AND QUICKTOX BUP DRUG SCREEN DIPCARD?

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

What is the FDA product code for FASTECT II BUP DRUG SCREEN DIPSTICK AND QUICKTOX BUP DRUG SCREEN DIPCARD?

The FDA product code for FASTECT II BUP DRUG SCREEN DIPSTICK AND QUICKTOX BUP DRUG SCREEN DIPCARD is DJG.

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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.