510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K910240Substantially Equivalent

Cholestat (Tm) Whole Blood Cholesterol Test

Crystal Diagnostics, Inc., Woburn MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K910240 is the FDA 510(k) clearance record for CHOLESTAT (TM) WHOLE BLOOD CHOLESTEROL TEST, a class I device, cleared for Crystal Diagnostics, Inc. on under FDA product code CHH (Enzymatic Esterase--Oxidase, Cholesterol). FDA records list 2 510(k) clearances for Crystal Diagnostics, Inc., from to . As of , FDA records show no recalls naming K910240.

Clearance record

Decision date
Received
(35 days to decision)
Product code
CHH Enzymatic Esterase--Oxidase, Cholesterol
Regulation
21 CFR 862.1175
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Crystal Diagnostics, Inc. 30 Commerce Way, Woburn MA
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