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

System, Automated Platelet Aggregation

21 CFR 864.5700 / Hematology
FDA source (opens on fda.gov)

JOZ is the FDA product code for System, Automated Platelet Aggregation, a class II device type, regulated under 21 CFR 864.5700. As of , FDA records hold 38 510(k) clearances under this code, the most recent dated , and 11 recalls.

Classification record

Product code
JOZ
Device name
System, Automated Platelet Aggregation
Regulation
21 CFR 864.5700
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
38
Ingested recalls
11

Clearances, product code JOZ

By decision year
38 clearances under product code JOZ with a decision year between 1977 and 2020, 1978 the highest year at 4.
Show the numbers
510(k) clearances under FDA product code JOZ by decision year
YearClearances
19772
19784
19792
19802
19851
19861
19941
19962
19971
19992
20013
20022
20031
20043
20052
20061
20121
20131
20152
20161
20171
20191
20201

Applicants with the most clearances

Product code JOZ
Applicants holding the most 510(k) clearances under product code JOZ
ApplicantClearances
Accumetrics, Inc.7
Chrono-Log Corp.6
Helena Laboratories, Corp.4
Aggredyne, Inc.3
Bio/Data Corp.2
Siemens Healthcare Diagnostics Inc.2
Array Medical, Inc.1
Bay Area Hema. Onco. Clinic. & Res. L1
Bellhouse Medical, Inc.1
Centocor, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 16 companies shown, in name order