Techlyte Electrolyte Analyzer

FDA 510(k) K905600 · Technalysis, Inc.

Substantially Equivalent

510(k) numberK905600

Submission

Device name
Techlyte Electrolyte Analyzer
Applicant
Technalysis, Inc.
Austin, TX, US
Received
December 14, 1990
Decision date
January 15, 1991
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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Questions and answers

When was Techlyte Electrolyte Analyzer cleared by the FDA?

Techlyte Electrolyte Analyzer (K905600) received a 510(k) decision of Substantially Equivalent on January 15, 1991, 32 days after the submission was received.

What is the product code of K905600?

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