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

Cell Enzymes (Erythrocytic And Leukocytic)

21 CFR 864.7100 / Hematology
FDA source (opens on fda.gov)

JBE is the FDA product code for Cell Enzymes (Erythrocytic And Leukocytic), a class II device type, regulated under 21 CFR 864.7100. As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
JBE
Device name
Cell Enzymes (Erythrocytic And Leukocytic)
Regulation
21 CFR 864.7100
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
1
Ingested recalls
0

Clearances, product code JBE

By decision year
1 clearance under product code JBE with a decision year between 1982 and 1982, 1982 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code JBE by decision year
YearClearances
19821

Applicants with the most clearances

Product code JBE
Applicants holding the most 510(k) clearances under product code JBE
ApplicantClearances
Sigma Chemical Co.1

Companies listing this code with FDA

Companies whose registered establishments list this code