510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K981345Substantially Equivalent

Cholestron Pro II Cholesterol Test

Lifestream Diagnostics, Inc., Los Angeles CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K981345 is the FDA 510(k) clearance record for CHOLESTRON PRO II CHOLESTEROL TEST, a class I device, cleared for Lifestream Diagnostics, Inc. on under FDA product code CHH (Enzymatic Esterase--Oxidase, Cholesterol). FDA records list one 510(k) clearance for Lifestream Diagnostics, Inc. As of , FDA records show no recalls naming K981345.

Clearance record

Decision date
Received
(170 days to decision)
Product code
CHH Enzymatic Esterase--Oxidase, Cholesterol
Regulation
21 CFR 862.1175
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Lifestream Diagnostics, Inc. 575 Shirlynn Ct., Los Angeles CA
510(k) summary
Summary
Third party review
No

Clearances, product code CHH

Trailing 12 months
1 clearance under product code CHH in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code CHH, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260