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

Aggregometer, Platelet, Photo-Optical Scanning

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

JBY is the FDA product code for Aggregometer, Platelet, Photo-Optical Scanning, a class II device type, regulated under 21 CFR 864.6675. As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
JBY
Device name
Aggregometer, Platelet, Photo-Optical Scanning
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
2
Ingested recalls
0

Clearances, product code JBY

By decision year
2 clearances under product code JBY with a decision year between 1977 and 1991, 1977 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code JBY by decision year
YearClearances
19771
19911

Applicants with the most clearances

Product code JBY
Applicants holding the most 510(k) clearances under product code JBY
ApplicantClearances
Chrono-Log Corp.1
Helena Laboratories, Corp.1

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code JBY.