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

Device, Automated Cell-Locating

21 CFR 864.5260 / Hematology
FDA source (opens on fda.gov)

JOY is the FDA product code for Device, Automated Cell-Locating, a class II device type, regulated under 21 CFR 864.5260. As of , FDA records hold 35 510(k) clearances under this code, the most recent dated , and 4 recalls.

Classification record

Product code
JOY
Device name
Device, Automated Cell-Locating
Regulation
21 CFR 864.5260
Device class
Class II
Review panel
Hematology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
35
Ingested recalls
4

Clearances, product code JOY

By decision year
35 clearances under product code JOY with a decision year between 1977 and 2025, 1997 the highest year at 4.
Show the numbers
510(k) clearances under FDA product code JOY by decision year
YearClearances
19771
19781
19931
19962
19974
19983
19991
20001
20011
20031
20042
20051
20062
20073
20081
20091
20101
20111
20171
20181
20202
20221
20231
20251

Applicants with the most clearances

Product code JOY
Applicants holding the most 510(k) clearances under product code JOY
ApplicantClearances
Cellavision AB7
Triangle Biomedical Sciences, Inc.5
Bioview4
Ikonisys, Inc.3
Scopio Labs Ltd.3
Accumed Intl., Inc.2
Applied Imaging Corp.2
Applied Spectral Imaging, Ltd.1
Chroma Vision Medical Systems, Inc.1
Geometric Data, Div. Smithkline Corp.1

Companies listing this code with FDA

Companies whose registered establishments list this code