Protoporphyrin ZN Control

FDA 510(k) K830493 · Kaulson Laboratories, Inc.

Substantially Equivalent

510(k) numberK830493

Submission

Device name
Protoporphyrin ZN Control
Applicant
Kaulson Laboratories, Inc.
Mchenry, IL, US
Received
February 16, 1983
Decision date
April 18, 1983
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
JJX – Single (Specified) Analyte Controls (Assayed And Unassayed)
Device class
Class I (low risk)
Regulation
21 CFR 862.1660
Specialty
Clinical Chemistry

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More from Siemens Healthcare Diagnostics, Inc.

510(k)DeviceDecision
K830494Contox Drug Screen ControlDIF · Traditional 03/11/1983SE
K830492Contox Durg ControlDIF · Traditional 03/11/1983SE
K830234Contox Heavymetals ControlDIF · Traditional 02/18/1983SE

Questions and answers

When was Protoporphyrin ZN Control cleared by the FDA?

Protoporphyrin ZN Control (K830493) received a 510(k) decision of Substantially Equivalent on April 18, 1983, 61 days after the submission was received.

What is the product code of K830493?

The FDA product code is JJX – Single (Specified) Analyte Controls (Assayed And Unassayed), a Class I (low risk) device regulated under 21 CFR 862.1660.