JFM — Enzymatic Method, Bilirubin Class II
FDA product code JFM covers "Enzymatic Method, Bilirubin", a Class II medical device regulated under 21 CFR 862.1110. Submissions are reviewed by the Clinical Chemistry panel. At least 11 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- JFM
- Device Class
- Class II
- Regulation Number
- 862.1110
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Clinical Chemistry
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K170065 | siemens healthcare diagnostics | ADVIA® Chemistry Total Bilirubin_2 (TBIL_2) | March 9, 2017 |
| K152343 | randox laboratories limited | Direct Bilirubin | February 16, 2016 |
| K152344 | randox laboratories limited | Total Bilirubin | January 28, 2016 |
| K063845 | bayer healthcare | ADVIA CHEMISTRY TOTAL BILIRUBIN_2 | December 7, 2007 |
| K053132 | wako chemicals usa | WAKO DIRECT BILIRUBIN V, MODELS 996-23591, 412-22901, 992-23691, 998-23791 | December 30, 2005 |
| K053131 | wako chemicals usa | WAKO TOTAL BILIRUBIN V, MODELS 410-22701, 998-23291, 416-22801, 990-23191 | December 30, 2005 |
| K053090 | beckman coulter | DRI-STAT ENZYMATIC BILIRUBIN REAGENT, SYNCHRON SYSTEMS BILIRUBIN CALIBRATOR | December 16, 2005 |
| K050266 | stanbio laboratory | DIRECT BILIRUBIN LIQUICOLOR AND TOTAL BILIRUBIN LIQUICOLOR | June 30, 2005 |
| K970985 | wako chemicals usa | WAKO TOTAL BILIRUBIN V | April 21, 1997 |
| K904660 | diagnostic chemicals, ltd. (usa) | ENZYMATIC BILIRUBIN (TOTAL), CATALOGUE NO. 202-14 | November 20, 1990 |
| K843174 | beckman instruments | DRI-STAT ENZYMATIC BILIRUBIN TEST KIT | September 14, 1984 |