FDA Product Code
FDA Product Code JHM — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1475
510(k) Clearances — 9 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K120662 | PICCOLO HDL-CAPILLARY TEST SYSTEM | Abaxis, Inc. | 2012-04-24 | Traditional | PDF ↗ |
| K081300 | DIMENSION VISTA HDLC FLEX REAGENT CARTRIDGE | Siemens Healthcare Diagnostics | 2008-07-02 | Special | PDF ↗ |
| K073072 | DIMENSION AHDL FLEX REAGENT CARTRIDGE, MODEL: DF48B | Dade Behring, Inc. | 2008-02-21 | Traditional | PDF ↗ |
| K032798 | DIMENSION AUTOMATED HDL CHOLESTEROL (AHDL) FLEX REAGENT CARTRIDGE (DF48A) CATALOG # DF48A | Dade Behring, Inc. | 2003-10-30 | Traditional | PDF ↗ |
| K022519 | LDL CHOLESTEROL (AUTOMATED) | Jas Diagnostics, Inc. | 2002-09-30 | Traditional | PDF ↗ |
| K983849 | DIMENSION AUTOMATED HIGH DENSITY LIPOPROTEIN CHOLESTEROL (ADHL) FLEX REAGENT CARTRIDGE | Dade Behring, Inc. | 1999-01-11 | Traditional | PDF ↗ |
| K902935 | ROCHE COBAS READY HDL CHOLESTEROL REAGENT | Roche Diagnostic Systems, Inc. | 1990-09-27 | Traditional | PDF ↗ |
| K841056 | HDL PRECIPITANT REAGENT SET | Medical Specialties, Inc. | 1984-05-01 | Traditional | PDF ↗ |
| K780173 | LYPOPROTEIN CHOLESTEROL TEST KIT | Environmental Chemical Specialties | 1978-05-03 | Traditional | PDF ↗ |
Product code JHM · Class I · Clinical Chemistry. Data: openFDA.