FDA product code JHM: Colorimetric Method, Lipoproteins
JHM is the FDA product code for colorimetric method, lipoproteins. It is a Class I device, regulated under 21 CFR 862.1475 and reviewed by the Clinical Chemistry panel. FDA has cleared 9 510(k) submissions under JHM, from 7 different applicants. The average 510(k) review took 70 days (median 62). FDA has posted 4 recalls for JHM devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Colorimetric Method, Lipoproteins |
| Device class | Class I |
| Regulation | 21 CFR 862.1475 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every JHM clearance
Top JHM applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Dade Behring, Inc. | 3 | 2008-02-21 |
| Abaxis, Inc. | 1 | 2012-04-24 |
| Siemens Healthcare Diagnostics | 1 | 2008-07-02 |
| Jas Diagnostics, Inc. | 1 | 2002-09-30 |
| Roche Diagnostic Systems, Inc. | 1 | 1990-09-27 |
2 more applicants have JHM clearances. See the full list in Caduvo.
Most recent JHM clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K120662 | Abaxis, Inc. | PICCOLO HDL-CAPILLARY TEST SYSTEM | 2012-04-24 | 50 |
| K081300 | Siemens Healthcare Diagnostics | DIMENSION VISTA HDLC FLEX REAGENT CARTRIDGE | 2008-07-02 | 55 |
| K073072 | Dade Behring, Inc. | DIMENSION AHDL FLEX REAGENT CARTRIDGE, MODEL: DF48B | 2008-02-21 | 113 |
| K032798 | Dade Behring, Inc. | DIMENSION AUTOMATED HDL CHOLESTEROL (AHDL) FLEX REAGENT CARTRIDGE (DF48A) CATALOG # DF48A | 2003-10-30 | 51 |
| K022519 | Jas Diagnostics, Inc. | LDL CHOLESTEROL (AUTOMATED) | 2002-09-30 | 62 |
Recalls for JHM devices
4 product recalls in 3 recall events; 1 initiated in the last five years and 2 still open. Most recent: 2022-08-24.
| Year | Recalls |
|---|---|
| 2021 | 1 |
| 2022 | 1 |
Frequently asked questions
What is FDA product code JHM?
JHM is the FDA product code for colorimetric method, lipoproteins. It is a Class I device, regulated under 21 CFR 862.1475 and reviewed by the Clinical Chemistry panel.
What device class is JHM?
Class I, regulation 21 CFR 862.1475. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code JHM?
Across 9 cleared submissions the average was 70 days from receipt to decision (median 62).
Which companies have the most JHM clearances?
Dade Behring, Inc. (3); Abaxis, Inc. (1); Siemens Healthcare Diagnostics (1); Jas Diagnostics, Inc. (1); Roche Diagnostic Systems, Inc. (1).
Have JHM devices been recalled?
Yes: 4 product recalls across 3 recall events; the most recent began 2022-08-24.
Next steps
- Run an FDA pathway report with predicate devices for product code JHM
- Run a recall and safety report across every JHM manufacturer
- Watch product code JHM for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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