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

Device, Hematocrit Measuring

21 CFR 864.6400 / Hematology
FDA source (opens on fda.gov)

JPI is the FDA product code for Device, Hematocrit Measuring, a class II device type, regulated under 21 CFR 864.6400. As of , FDA records hold 15 510(k) clearances under this code, the most recent dated , and 9 recalls.

Classification record

Product code
JPI
Device name
Device, Hematocrit Measuring
Regulation
21 CFR 864.6400
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
15
Ingested recalls
9

Clearances, product code JPI

By decision year
15 clearances under product code JPI with a decision year between 1982 and 2020, 1983 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code JPI by decision year
YearClearances
19821
19833
19841
19853
19871
19902
19931
19951
20171
20201

Applicants with the most clearances

Product code JPI
Applicants holding the most 510(k) clearances under product code JPI
ApplicantClearances
Abbott Medical2
Fisher Scientific Company L.L.C.2
Norfolk Scientific, Inc.2
Biodynamics Corp.1
Em Diagnostic Systems, Inc.1
Hans J. Brouwers & Assoc.1
Heraeus-Christ GmbH1
In-Line Diagnostics Corp.1
Noninvasive Medical Technology Corp.1
Statspin Technologies1

Companies listing this code with FDA

Companies whose registered establishments list this code