Lytening 6 Sodium/Potassium/Ionized Calcium Analyz

FDA 510(k) K884731 · Amdev, Inc.

Substantially Equivalent

510(k) numberK884731

Submission

Device name
Lytening 6 Sodium/Potassium/Ionized Calcium Analyz
Applicant
Amdev, Inc.
Danvers, MA, US
Received
November 10, 1988
Decision date
February 3, 1989
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
JFP – Electrode, Ion Specific, Calcium
Device class
Class II (moderate risk)
Regulation
21 CFR 862.1145
Specialty
Clinical Chemistry

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K152327EasyLyte Na/K/Cl/Ca AnalyzerJFP · Traditional Medica Corporation12/01/2016SE
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K963694Easylyte Calcium/Chloride AnalyzerJFP · Traditional Medica Corp.11/27/1996SE
K961458Avl 9180 Electrolyte AnalyzerJFP · Traditional Avl Scientific Corp.06/12/1996SE
K960120Stat Profile Ultra F,G,H,I,J, and K AnalyzersJFP · Traditional Nova Biomedical Corp.03/11/1996SE
K943091Easy Lyte Calcium AnalyzerJFP · Traditional Medica Corp.01/17/1995SE

More from Medica Corp.

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K904726Lytening TM 6/RJFP · Traditional 12/18/1990SE
K890524Apec Glucose AnalyzerCGA · Traditional 03/15/1989SE
K880917Lytening 5JGS · Traditional 05/27/1988SE
K863521Lytening 2JGS · Traditional 11/05/1986SE
K853832Lytening 1JGS · Traditional 10/04/1985SE

Questions and answers

When was Lytening 6 Sodium/Potassium/Ionized Calcium Analyz cleared by the FDA?

Lytening 6 Sodium/Potassium/Ionized Calcium Analyz (K884731) received a 510(k) decision of Substantially Equivalent on February 3, 1989, 85 days after the submission was received.

What is the product code of K884731?

The FDA product code is JFP – Electrode, Ion Specific, Calcium, a Class II (moderate risk) device regulated under 21 CFR 862.1145.