Electrolyte Analyzer SERA-210

FDA 510(k) K841424 · Horiba Instruments, Inc.

Substantially Equivalent

510(k) numberK841424

Submission

Device name
Electrolyte Analyzer SERA-210
Applicant
Horiba Instruments, Inc.
Walker, MI, US
Received
April 6, 1984
Decision date
June 22, 1984
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
JGS – Electrode, Ion Specific, Sodium
Device class
Class II (moderate risk)
Regulation
21 CFR 862.1665
Specialty
Clinical Chemistry

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More from Instrumentation Laboratory CO

510(k)DeviceDecision
K853405Electrolyte Analyzer SERA-252CHL · Traditional 12/04/1985SE
K853356SERA-210 Electrolyte AnalyzerCEM · Traditional 09/03/1985SE
K844806Modify Electrolyte Analyzer Model SERA-210CEM · Traditional 01/08/1985SE
K841441SERA-250 · Traditional 04/06/1984SESP

Questions and answers

When was Electrolyte Analyzer SERA-210 cleared by the FDA?

Electrolyte Analyzer SERA-210 (K841424) received a 510(k) decision of Substantially Equivalent on June 22, 1984, 77 days after the submission was received.

What is the product code of K841424?

The FDA product code is JGS – Electrode, Ion Specific, Sodium, a Class II (moderate risk) device regulated under 21 CFR 862.1665.