510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K853871Substantially Equivalent

Qca Enzymatic Cholesterol

BD Becton Dickinson Vacutainer Systems Preanalytic, Paramus NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K853871 is the FDA 510(k) clearance record for QCA ENZYMATIC CHOLESTEROL, a class I device, cleared for Bd Becton Dickinson Vacutainer Systems Preanalytic on under FDA product code CHH (Enzymatic Esterase--Oxidase, Cholesterol). FDA records list 632 510(k) clearances for Bd Becton Dickinson Vacutainer Systems Preanalytic, from to . As of , FDA records show no recalls naming K853871.

Clearance record

Decision date
Received
(17 days to decision)
Product code
CHH Enzymatic Esterase--Oxidase, Cholesterol
Regulation
21 CFR 862.1175
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Bd Becton Dickinson Vacutainer Systems Preanalytic Mack Centre Dr., Paramus NJ
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