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

Lymphocyte Separation Medium

21 CFR 864.8500 / Hematology
FDA source (opens on fda.gov)

JCF is the FDA product code for Lymphocyte Separation Medium, a class I device type, regulated under 21 CFR 864.8500. As of , FDA records hold 12 510(k) clearances under this code, the most recent dated , and 4 recalls.

Classification record

Product code
JCF
Device name
Lymphocyte Separation Medium
Regulation
21 CFR 864.8500
Device class
Class I
Review panel
Hematology
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
12
Ingested recalls
4

Clearances, product code JCF

By decision year
12 clearances under product code JCF with a decision year between 1981 and 1992, 1984 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code JCF by decision year
YearClearances
19811
19821
19842
19851
19861
19872
19881
19891
19901
19921

Applicants with the most clearances

Product code JCF
Applicants holding the most 510(k) clearances under product code JCF
ApplicantClearances
BD Becton Dickinson Vacutainer Systems Preanalytic5
Dynal Biotech, Inc.1
E.I. Dupont de Nemours & Co., Inc.1
Flow Laboratories, Inc.1
Icn Biomedicals, Inc.1
Kallestad Laboratories, Inc.1
Sepratech Corporation C/O Keller and Heckman1
Sigma Chemical Co.1

Companies listing this code with FDA

Companies whose registered establishments list this code