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

Test, Euglobulin Lysis

21 CFR 864.7275 / Hematology
FDA source (opens on fda.gov)

JBO is the FDA product code for Test, Euglobulin Lysis, a class II device type, regulated under 21 CFR 864.7275. As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
JBO
Device name
Test, Euglobulin Lysis
Regulation
21 CFR 864.7275
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
1
Ingested recalls
0

Clearances, product code JBO

By decision year
1 clearance under product code JBO with a decision year between 1983 and 1983, 1983 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code JBO by decision year
YearClearances
19831

Applicants with the most clearances

Product code JBO
Applicants holding the most 510(k) clearances under product code JBO
ApplicantClearances
Olympus 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 JBO.