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

Colorimetric Method, Lipoproteins

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

JHM is the FDA product code for Colorimetric Method, Lipoproteins, a class I device type, regulated under 21 CFR 862.1475. As of , FDA records hold 9 510(k) clearances under this code, the most recent dated , and 4 recalls.

Classification record

Product code
JHM
Device name
Colorimetric Method, 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
9
Ingested recalls
4

Clearances, product code JHM

By decision year
9 clearances under product code JHM with a decision year between 1978 and 2012, 2008 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code JHM by decision year
YearClearances
19781
19841
19901
19991
20021
20031
20082
20121

Applicants with the most clearances

Product code JHM
Applicants holding the most 510(k) clearances under product code JHM
ApplicantClearances
Siemens Healthcare Diagnostics Inc.4
Abaxis Inc1
Environmental Chemical Specialties1
JAS Diagnostics/Drew Scientific1
Medical Specialties Inc.1
Roche Diagnostic Systems, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code