Lifestream Plus Cholesterol Monitor, Modification to Resolution Cholesterol Monitor

FDA 510(k) K033899 · Lifestream Technologies, Inc.

Substantially Equivalent

510(k) numberK033899

Submission

Device name
Lifestream Plus Cholesterol Monitor, Modification to Resolution Cholesterol Monitor
Applicant
Lifestream Technologies, Inc.
Post Falls, ID, US
Received
December 17, 2003
Decision date
May 20, 2004
Decision
Substantially Equivalent (SESE)
Type
Special 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
NFX – Test, Cholesterol, Total, Over The Counter
Device class
Class I (low risk)
Regulation
21 CFR 862.1175
Specialty
Clinical Chemistry

More from Lifestream Technologies, Inc.

510(k)DeviceDecision
K000610Resolution Cholesterol MonitorCHH · Traditional 07/21/2000SE
K993096Privalink Software Accessory to the Lifestream Cholesterol MonitorCHH · Traditional 12/20/1999SE

Questions and answers

When was Lifestream Plus Cholesterol Monitor, Modification to Resolution Cholesterol Monitor cleared by the FDA?

Lifestream Plus Cholesterol Monitor, Modification to Resolution Cholesterol Monitor (K033899) received a 510(k) decision of Substantially Equivalent on May 20, 2004, 155 days after the submission was received.

What is the product code of K033899?

The FDA product code is NFX – Test, Cholesterol, Total, Over The Counter, a Class I (low risk) device regulated under 21 CFR 862.1175.