CFM — Bathophenanthroline, Colorimetry, Iron (Non-Heme) Class I
FDA product code CFM covers "Bathophenanthroline, Colorimetry, Iron (Non-Heme)", a Class I medical device regulated under 21 CFR 862.1410. Submissions are reviewed by the Clinical Chemistry panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- CFM
- Device Class
- Class I
- Regulation Number
- 862.1410
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Clinical Chemistry
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K984119 | wako chemicals usa | WAKO L-TYPE FE, WAKO L-TYPE CALIBRATOR | January 15, 1999 |
| K981581 | abbott laboratories | IRON | June 8, 1998 |
| K932871 | catachem | UIBC FOR DISCREET RANDOM ACCESS ANALYZER | September 8, 1993 |
| K913705 | em diagnostic systems | ABBOTT QLUICKSTART IRON TEST, ITEM #5A29 | October 9, 1991 |
| K912912 | synermed | SYNERMED SERUM IRON-600 REAGENT KIT | July 30, 1991 |
| K902918 | synermed | SYNERMED SERUM IRON REAGENT KIT | July 31, 1990 |
| K895047 | heraeus kulzer | CLINISTAT POTASSIUM REAGENT TEST | October 17, 1989 |
| K891155 | medical analysis systems | IRON REAGENT | April 18, 1989 |
| K873120 | abbott laboratories | ABBOTT A-GENT IRON REAGENT KIT | August 25, 1987 |
| K861602 | data medical associates | TOTAL IRON BINDING CAPACITY PROCEDURE | May 23, 1986 |
| K854305 | coulter electronics | DART IRON & IRON BINDING CAPACITY REAGENT | November 12, 1985 |
| K852583 | data medical associates | DATA CHEM IRON PROCEDURE | July 12, 1985 |
| K842156 | diagnostic chemicals, ltd. (usa) | SERUM IRON & SERUM IRON BINDING CAPACITY | August 7, 1984 |
| K842155 | diagnostic chemicals, ltd. (usa) | SERUM IRON & SERUM IRON BINDING CAPACI | August 7, 1984 |
| K842505 | abbott laboratories | TDX REA IRON DIAGNOSTIC KIT | August 7, 1984 |
| K840485 | somas medical industries | TOTAL IRON UIBC/TIBC ASSAY | March 12, 1984 |
| K834396 | seragen diagnostics | DIRECT IRON REAGENT SET | February 21, 1984 |
| K830564 | wako chemicals usa | FEB TEST | March 29, 1983 |
| K820629 | corning medical and scientific | CORNING 902 SODIUM POTASSIUM ANALYZER | March 25, 1982 |
| K810085 | bio-analytics laboratories | IRON KIT | January 28, 1981 |