510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K873185Substantially Equivalent

Dynabeads Hla Cell Prep II Isolation Product

Dynal Biotech, Inc., Great Neck NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K873185 is the FDA 510(k) clearance record for DYNABEADS HLA CELL PREP II ISOLATION PRODUCT, a class I device, cleared for Dynal Biotech, Inc. on under FDA product code JCF (Lymphocyte Separation Medium). FDA records list one 510(k) clearance for Dynal Biotech, Inc. As of , FDA records show no recalls naming K873185.

Clearance record

Decision date
Received
(84 days to decision)
Product code
JCF Lymphocyte Separation Medium
Regulation
21 CFR 864.8500
Device class
Class I
Review panel
Hematology
Applicant
Dynal Biotech, Inc. 45 N. Station Plz., Great Neck NY
Third party review
No

Clearances, product code JCF

Trailing 12 months

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

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