510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K033899Substantially Equivalent

Lifestream Plus Cholesterol Monitor, Modification to Resolution Cholesterol Monitor

Lifestream Technologies, Inc., Post Falls ID / Special, Substantially Equivalent
FDA source (opens on fda.gov)

K033899 is the FDA 510(k) clearance record for LIFESTREAM PLUS CHOLESTEROL MONITOR, MODIFICATION TO RESOLUTION CHOLESTEROL MONITOR, a class I device, cleared for Lifestream Technologies, Inc. on under FDA product code NFX (Test, Cholesterol, Total, Over The Counter). FDA records list 3 510(k) clearances for Lifestream Technologies, Inc., from to . As of , FDA records show no recalls naming K033899.

Clearance record

Decision date
Received
(155 days to decision)
Product code
NFX Test, Cholesterol, Total, Over The Counter
Regulation
21 CFR 862.1175
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Lifestream Technologies, Inc. 510 Clearwater Loop, Suite 101, Post Falls ID
510(k) summary
Statement
Third party review
No

Clearances, product code NFX

Trailing 12 months

FDA records hold no clearances under product code NFX in the trailing twelve months.

FDA records show no clearances under product code NFX in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code NFX, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260