Contox Heavymetals Control

FDA 510(k) K830234 · Kaulson Laboratories, Inc.

Substantially Equivalent

510(k) numberK830234

Submission

Device name
Contox Heavymetals Control
Applicant
Kaulson Laboratories, Inc.
Mchenry, IL, US
Received
January 25, 1983
Decision date
February 18, 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.

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Questions and answers

When was Contox Heavymetals Control cleared by the FDA?

Contox Heavymetals Control (K830234) received a 510(k) decision of Substantially Equivalent on February 18, 1983, 24 days after the submission was received.

What is the product code of K830234?

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