Contox Drug Screen Control

FDA 510(k) K830494 · Kaulson Laboratories, Inc.

Substantially Equivalent

510(k) numberK830494

Submission

Device name
Contox Drug Screen Control
Applicant
Kaulson Laboratories, Inc.
Mchenry, IL, US
Received
February 16, 1983
Decision date
March 11, 1983
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

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 Roche Diagnostics Corp.

510(k)DeviceDecision
K830493Protoporphyrin ZN ControlJJX · Traditional 04/18/1983SE
K830492Contox Durg ControlDIF · Traditional 03/11/1983SE
K830234Contox Heavymetals ControlDIF · Traditional 02/18/1983SE

Questions and answers

When was Contox Drug Screen Control cleared by the FDA?

Contox Drug Screen Control (K830494) received a 510(k) decision of Substantially Equivalent on March 11, 1983, 23 days after the submission was received.

What is the product code of K830494?

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