510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K894279Substantially Equivalent

Luteinizing Hormone Mab Solid Phase Component Syst

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

K894279 is the FDA 510(k) clearance record for LUTEINIZING HORMONE MAB SOLID PHASE COMPONENT SYST, a class I device, cleared for Bd Becton Dickinson Vacutainer Systems Preanalytic on under FDA product code CEP (Radioimmunoassay, Luteinizing Hormone). FDA records list 632 510(k) clearances for Bd Becton Dickinson Vacutainer Systems Preanalytic, from to . As of , FDA records show no recalls naming K894279.

Clearance record

Decision date
Received
(53 days to decision)
Product code
CEP Radioimmunoassay, Luteinizing Hormone
Regulation
21 CFR 862.1485
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Bd Becton Dickinson Vacutainer Systems Preanalytic 1 Becton Dr., Franklin Lakes NJ
Third party review
No

Clearances, product code CEP

Trailing 12 months

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

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