Product code JHM— Clinical Chemistry
DIMENSION AHDL FLEX REAGENT CARTRIDGE, MODEL: DF48B
- Classification name
- Colorimetric Method, Lipoproteins
- Device class
- Class 1
- Regulation
- 21 CFR 862.1475
- Advisory panel
- Clinical Chemistry
- Total cleared
- 9
- First cleared
- Most recent
Market context for product code JHM
FDA has cleared devices under product code JHM between 1978 and 2012, filed by 7 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.
Clearances per year
- 2012
- 2008
- 2003
- 2002
- 1999
- 1990
- 1984
- 1978
Top applicants under product code JHM
Recent clearances under product code JHM
- K120662 — PICCOLO HDL-CAPILLARY TEST SYSTEM
- K081300 — DIMENSION VISTA HDLC FLEX REAGENT CARTRIDGE
- K073072 — DIMENSION AHDL FLEX REAGENT CARTRIDGE, MODEL: DF48B
- K032798 — DIMENSION AUTOMATED HDL CHOLESTEROL (AHDL) FLEX REAGENT CARTRIDGE (DF48A) CATALOG # DF48A
- K022519 — LDL CHOLESTEROL (AUTOMATED)
- K983849 — DIMENSION AUTOMATED HIGH DENSITY LIPOPROTEIN CHOLESTEROL (ADHL) FLEX REAGENT CARTRIDGE
- K902935 — ROCHE COBAS READY HDL CHOLESTEROL REAGENT
- K841056 — HDL PRECIPITANT REAGENT SET
- K780173 — LYPOPROTEIN CHOLESTEROL TEST KIT
Data sourced from openFDA. This site is unofficial and independent of the FDA.