JHM
9 FDA 510(k) clearances · Product code
62 daysmedian time to decision
113 days90th percentile
9clearances measured
FDA profile
- Official device name
- Colorimetric Method, Lipoproteins
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1475
- Medical specialty
- Clinical Chemistry
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| PICCOLO HDL-CAPILLARY TEST SYSTEM (K120662) | Abaxis, Inc. | 2012-04-24 |
| DIMENSION VISTA HDLC FLEX REAGENT CARTRIDGE (K081300) | Siemens Healthcare Diagnostics | 2008-07-02 |
| DIMENSION AHDL FLEX REAGENT CARTRIDGE, MODEL: DF48B (K073072) | Dade Behring, Inc. | 2008-02-21 |
| DIMENSION AUTOMATED HDL CHOLESTEROL (AHDL) FLEX REAGENT CARTRIDGE (DF48A) CATALOG # DF48A (K032798) | Dade Behring, Inc. | 2003-10-30 |
| LDL CHOLESTEROL (AUTOMATED) (K022519) | Jas Diagnostics, Inc. | 2002-09-30 |
| DIMENSION AUTOMATED HIGH DENSITY LIPOPROTEIN CHOLESTEROL (ADHL) FLEX REAGENT CARTRIDGE (K983849) | Dade Behring, Inc. | 1999-01-11 |
| ROCHE COBAS READY HDL CHOLESTEROL REAGENT (K902935) | Roche Diagnostic Systems, Inc. | 1990-09-27 |
| HDL PRECIPITANT REAGENT SET (K841056) | Medical Specialties, Inc. | 1984-05-01 |
| LYPOPROTEIN CHOLESTEROL TEST KIT (K780173) | Environmental Chemical Specialties | 1978-05-03 |
Track JHM automatically
Every clearance here is in the API, with alerts when new ones post.