Privalink Software Accessory to the Lifestream Cholesterol Monitor

FDA 510(k) K993096 · Lifestream Technologies, Inc.

Substantially Equivalent

510(k) numberK993096

Submission

Device name
Privalink Software Accessory to the Lifestream Cholesterol Monitor
Applicant
Lifestream Technologies, Inc.
Post Falls, ID, US
Received
May 28, 1999
Decision date
December 20, 1999
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
CHH – Enzymatic Esterase--Oxidase, Cholesterol
Device class
Class I (low risk)
Regulation
21 CFR 862.1175
Specialty
Clinical Chemistry

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More from Axis-Shield Poc AS

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Questions and answers

When was Privalink Software Accessory to the Lifestream Cholesterol Monitor cleared by the FDA?

Privalink Software Accessory to the Lifestream Cholesterol Monitor (K993096) received a 510(k) decision of Substantially Equivalent on December 20, 1999, 206 days after the submission was received.

What is the product code of K993096?

The FDA product code is CHH – Enzymatic Esterase--Oxidase, Cholesterol, a Class I (low risk) device regulated under 21 CFR 862.1175.