Product code JFM— Clinical Chemistry
ADVIA CHEMISTRY TOTAL BILIRUBIN_2
- Classification name
- Enzymatic Method, Bilirubin
- Device class
- Class 2
- Regulation
- 21 CFR 862.1110
- Advisory panel
- Clinical Chemistry
- Total cleared
- 11
- First cleared
- Most recent
Market context for product code JFM
FDA has cleared devices under product code JFM between 1984 and 2017, filed by 8 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2017
- 2016
- 2007
- 2005
- 1997
- 1990
- 1984
Top applicants under product code JFM
Recent clearances under product code JFM
- K170065 — ADVIA® Chemistry Total Bilirubin_2 (TBIL_2)
- K152343 — Direct Bilirubin
- K152344 — Total Bilirubin
- K063845 — ADVIA CHEMISTRY TOTAL BILIRUBIN_2
- K053131 — WAKO TOTAL BILIRUBIN V, MODELS 410-22701, 998-23291, 416-22801, 990-23191
- K053132 — WAKO DIRECT BILIRUBIN V, MODELS 996-23591, 412-22901, 992-23691, 998-23791
- K053090 — DRI-STAT ENZYMATIC BILIRUBIN REAGENT, SYNCHRON SYSTEMS BILIRUBIN CALIBRATOR
- K050266 — DIRECT BILIRUBIN LIQUICOLOR AND TOTAL BILIRUBIN LIQUICOLOR
- K970985 — WAKO TOTAL BILIRUBIN V
- K904660 — ENZYMATIC BILIRUBIN (TOTAL), CATALOGUE NO. 202-14
- K843174 — DRI-STAT ENZYMATIC BILIRUBIN TEST KIT
Data sourced from openFDA. This site is unofficial and independent of the FDA.