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

Electrophoretic Separation, Lipoproteins

21 CFR 862.1475 / Clinical Chemistry
FDA source (opens on fda.gov)

JHO is the FDA product code for Electrophoretic Separation, Lipoproteins, a class I device type, regulated under 21 CFR 862.1475. As of , FDA records hold 26 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
JHO
Device name
Electrophoretic Separation, Lipoproteins
Regulation
21 CFR 862.1475
Device class
Class I
Review panel
Clinical Chemistry
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
26
Ingested recalls
0

Clearances, product code JHO

By decision year
26 clearances under product code JHO with a decision year between 1978 and 2002, 2002 the highest year at 4.
Show the numbers
510(k) clearances under FDA product code JHO by decision year
YearClearances
19781
19792
19801
19841
19851
19871
19881
19891
19942
19963
19971
19983
19991
20001
20012
20024

Applicants with the most clearances

Product code JHO
Applicants holding the most 510(k) clearances under product code JHO
ApplicantClearances
Helena Laboratories, Corp.15
Beckman Instruments, Inc.2
Morax2
Quantimetrix Corp.2
Corning Medical & Scientific1
Gelman Sciences, Inc.1
Sebia1
Strategic Diagnostics, Inc.1
Zaxis, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code