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

Control, Cell Counter, Normal And Abnormal

21 CFR 864.8625 / Hematology
FDA source (opens on fda.gov)

JCN is the FDA product code for Control, Cell Counter, Normal And Abnormal, a class II device type, regulated under 21 CFR 864.8625. As of , FDA records hold 12 510(k) clearances under this code, the most recent dated , and 3 recalls.

Classification record

Product code
JCN
Device name
Control, Cell Counter, Normal And Abnormal
Regulation
21 CFR 864.8625
Device class
Class II
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
3

Clearances, product code JCN

By decision year
12 clearances under product code JCN with a decision year between 1982 and 1999, 1989 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code JCN by decision year
YearClearances
19821
19871
19893
19903
19911
19931
19941
19991

Applicants with the most clearances

Product code JCN
Applicants holding the most 510(k) clearances under product code JCN
ApplicantClearances
Streck Laboratories, Inc.4
R & D Systems, Inc.3
Baker Instructions Corp.1
Bio-Rad1
Hematronix, Inc.1
Medical Specialties Intl., Inc.1
Unipath, Ltd.1

Companies listing this code with FDA

Companies whose registered establishments list this code