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

Red-Cell Indices, Calculated

21 CFR 864.5300 / Hematology
FDA source (opens on fda.gov)

JPJ is the FDA product code for Red-Cell Indices, Calculated, a class II device type, regulated under 21 CFR 864.5300. As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
JPJ
Device name
Red-Cell Indices, Calculated
Regulation
21 CFR 864.5300
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
3
Ingested recalls
0

Clearances, product code JPJ

By decision year
3 clearances under product code JPJ with a decision year between 1977 and 1990, 1977 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code JPJ by decision year
YearClearances
19771
19781
19901

Applicants with the most clearances

Product code JPJ
Applicants holding the most 510(k) clearances under product code JPJ
ApplicantClearances
BD Becton Dickinson Vacutainer Systems Preanalytic1
Hycel, Inc.1
J.T. Baker Chemical Co.1

Companies listing this code with FDA

Companies whose registered establishments list this code

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