Solution B- Na 50MEQ/L, K 40 Meq/L

FDA 510(k) K863502 · Reagent Laboratory, Inc.

Substantially Equivalent

510(k) numberK863502

Submission

Device name
Solution B- Na 50MEQ/L, K 40 Meq/L
Applicant
Reagent Laboratory, Inc.
Louisville, KY, US
Received
September 9, 1986
Decision date
October 21, 1986
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.

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K860143Urine Diluent-For Use with Ion Selective ElectrodeJJP · Traditional 02/10/1986SE
K842982Formalin BufferedIFP · Traditional 10/01/1984SE
K843050Gram StainJTS · Traditional 09/11/1984SE
K842785Stain, Methylene Blue-EosinKFC · Traditional 09/11/1984SE
K841847Lithium ReagentJJO · Traditional 08/17/1984SE
K843051Wrights Stain Solution · Traditional 08/03/1984SESP
K841800Lysing & Hemoglobin ReagentGGK · Traditional 05/31/1984SE
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Questions and answers

When was Solution B- Na 50MEQ/L, K 40 Meq/L cleared by the FDA?

Solution B- Na 50MEQ/L, K 40 Meq/L (K863502) received a 510(k) decision of Substantially Equivalent on October 21, 1986, 42 days after the submission was received.

What is the product code of K863502?

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