510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
JBXClass II

Aggregrometer, Platelet

21 CFR 864.6675 / Hematology
FDA source (opens on fda.gov)

JBX is the FDA product code for Aggregrometer, Platelet, a class II device type, regulated under 21 CFR 864.6675. As of , FDA records hold 12 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
JBX
Device name
Aggregrometer, Platelet
Regulation
21 CFR 864.6675
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
12
Ingested recalls
0

Clearances, product code JBX

By decision year
12 clearances under product code JBX with a decision year between 1976 and 1993, 1983 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code JBX by decision year
YearClearances
19761
19781
19811
19821
19832
19852
19861
19881
19911
19931

Applicants with the most clearances

Product code JBX
Applicants holding the most 510(k) clearances under product code JBX
ApplicantClearances
Chrono-Log Corp.5
Bio/Data Corp.2
American Bioproducts Co.1
Diagnostica, Inc.1
Helena Laboratories, Corp.1
Sigma Chemical Co.1
Streck Laboratories, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code