Detectabuse Liquid Control, Detectabuse Stat-Skreen Liquid Control

FDA 510(k) K121122 · Biochemical Diagnostic, Inc.

Substantially Equivalent

510(k) numberK121122

Submission

Device name
Detectabuse Liquid Control, Detectabuse Stat-Skreen Liquid Control
Applicant
Biochemical Diagnostic, Inc.
Edgewood, NY, US
Received
April 13, 2012
Decision date
July 3, 2012
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
DIF – Drug Mixture Control Materials
Device class
Class I (low risk)
Regulation
21 CFR 862.3280
Specialty
Clinical Toxicology

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More from Bio-Rad, Diagnostics Grp.

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K050328Pregnancy-SkreenJJX · Traditional 03/29/2005SE
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Questions and answers

When was Detectabuse Liquid Control, Detectabuse Stat-Skreen Liquid Control cleared by the FDA?

Detectabuse Liquid Control, Detectabuse Stat-Skreen Liquid Control (K121122) received a 510(k) decision of Substantially Equivalent on July 3, 2012, 81 days after the submission was received.

What is the product code of K121122?

The FDA product code is DIF – Drug Mixture Control Materials, a Class I (low risk) device regulated under 21 CFR 862.3280.