Km-Kal L2

FDA 510(k) K823043 · Kmn Products, Inc.

Substantially Equivalent

510(k) numberK823043

Submission

Device name
Km-Kal L2
Applicant
Kmn Products, Inc.
Mchenry, IL, US
Received
October 15, 1982
Decision date
November 5, 1982
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
JIX – Calibrator, Multi-Analyte Mixture
Device class
Class II (moderate risk)
Regulation
21 CFR 862.1150
Specialty
Clinical Chemistry

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More from Siemens Healthcare Diagnostics, Inc.

510(k)DeviceDecision
K823044Km-Kal L3JIX · Traditional 12/09/1982SE
K823025KM - Kal 2JIT · Traditional 11/16/1982SE
K823024KM - Kal 1JIT · Traditional 11/16/1982SE
K823023Km-Kal L6JIT · Traditional 11/16/1982SE
K823022Km-Kal 6JIT · Traditional 11/16/1982SE
K823021KM - Kal 5JIT · Traditional 11/16/1982SE
K823020Km-Kal 4JIT · Traditional 11/16/1982SE
K823019Km-Kal 3JIT · Traditional 11/16/1982SE
K823046Km-Kal L5JIX · Traditional 11/05/1982SE
K823045Km-Kal L4JIX · Traditional 11/05/1982SE

Questions and answers

When was Km-Kal L2 cleared by the FDA?

Km-Kal L2 (K823043) received a 510(k) decision of Substantially Equivalent on November 5, 1982, 21 days after the submission was received.

What is the product code of K823043?

The FDA product code is JIX – Calibrator, Multi-Analyte Mixture, a Class II (moderate risk) device regulated under 21 CFR 862.1150.