510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K150815Substantially Equivalent

BD FACSPresto System, BD FACSPresto CD4/Hb Cartridge, BD FACSPresto CD4/Hb Cartridge Kit

Becton Dickinson & Co, San Jose CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K150815 is the FDA 510(k) clearance record for BD FACSPresto System, BD FACSPresto CD4/Hb Cartridge, BD FACSPresto CD4/Hb Cartridge Kit, a class II device, cleared for Becton, Dickinson and Company on under FDA product code PMG (Automated Multicolor Fluorescent Imaging Cytometric Analysis System). FDA's definition for product code PMG reads: "An automated multicolor fluorescent imaging cytometer and absorbance spectrometer which utilizes specific single-use reagent cartridges to identify and enumerate specific hematologic subpopulations and parameters (e.g., hemoglobin) using...". FDA records list 345 510(k) clearances for Becton, Dickinson and Company, from to . As of , FDA records show one recall naming K150815.

Clearance record

Decision date
Received
(265 days to decision)
Product code
PMG Automated Multicolor Fluorescent Imaging Cytometric Analysis System
Regulation
21 CFR 864.5220
Device class
Class II
Review panel
Hematology
Applicant
Becton, Dickinson and Company 2350 Qume Dr., San Jose CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PMG

Trailing 12 months

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

FDA records show no clearances under product code PMG in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code PMG, 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