510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
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K183205Unknown

PureBMC SupraPhysiologic Concentrating System 30 mL System, PureBMC SupraPhysiologic Concentrating System 60 mL System, PureBMC SupraPhysiologic Concentrating System 120 mL System

EmCyte Corporation, Fort Meyers FL / Special, Unknown
FDA source (opens on fda.gov)

K183205 is the FDA 510(k) clearance record for PureBMC SupraPhysiologic Concentrating System 30 mL System, PureBMC SupraPhysiologic Concentrating System 60 mL System, PureBMC SupraPhysiologic Concentrating System 120 mL System, a class I device, cleared for Emcyte Corporation on under FDA product code JQC (Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use). FDA records list 2 510(k) clearances for Emcyte Corporation, from to . As of , FDA records show no recalls naming K183205.

Clearance record

Decision date
Received
(192 days to decision)
Product code
JQC Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use
Regulation
21 CFR 862.2050
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Emcyte Corporation 4331 Veronica S. Shoemaker Blvd., Suite 4, Fort Meyers FL
510(k) summary
Statement
Third party review
No

Clearances, product code JQC

Trailing 12 months

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

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