FDA Product Code
FDA Product Code CFM — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1410
510(k) Clearances — 21 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K984119 | WAKO L-TYPE FE, WAKO L-TYPE CALIBRATOR | Wako Chemicals USA, Inc. | 1999-01-15 | Traditional | PDF ↗ |
| K981581 | IRON | Abbott Laboratories | 1998-06-08 | Traditional | PDF ↗ |
| K932871 | UIBC FOR DISCREET RANDOM ACCESS ANALYZER | Catachem, Inc. | 1993-09-08 | Traditional | PDF ↗ |
| K913705 | ABBOTT QLUICKSTART IRON TEST, ITEM #5A29 | Em Diagnostic Systems, Inc. | 1991-10-09 | Traditional | PDF ↗ |
| K912912 | SYNERMED SERUM IRON-600 REAGENT KIT | Synermed, Inc. | 1991-07-30 | Traditional | PDF ↗ |
| K902918 | SYNERMED SERUM IRON REAGENT KIT | Synermed, Inc. | 1990-07-31 | Traditional | PDF ↗ |
| K895047 | CLINISTAT POTASSIUM REAGENT TEST | Heraeus Kulzer, Inc. | 1989-10-17 | Traditional | PDF ↗ |
| K891155 | IRON REAGENT | Medical Analysis Systems, Inc. | 1989-04-18 | Traditional | PDF ↗ |
| K873120 | ABBOTT A-GENT IRON REAGENT KIT | Abbott Laboratories | 1987-08-25 | Traditional | PDF ↗ |
| K861602 | TOTAL IRON BINDING CAPACITY PROCEDURE | Data Medical Associates, Inc. | 1986-05-23 | Traditional | PDF ↗ |
| K854305 | DART IRON & IRON BINDING CAPACITY REAGENT | Coulter Electronics, Inc. | 1985-11-12 | Traditional | PDF ↗ |
| K852583 | DATA CHEM IRON PROCEDURE | Data Medical Associates, Inc. | 1985-07-12 | Traditional | PDF ↗ |
| K842505 | TDX REA IRON DIAGNOSTIC KIT | Abbott Laboratories | 1984-08-07 | Traditional | PDF ↗ |
| K842155 | SERUM IRON & SERUM IRON BINDING CAPACI | Diagnostic Chemicals, Ltd. (Usa) | 1984-08-07 | Traditional | PDF ↗ |
| K842156 | SERUM IRON & SERUM IRON BINDING CAPACITY | Diagnostic Chemicals, Ltd. (Usa) | 1984-08-07 | Traditional | PDF ↗ |
| K840485 | TOTAL IRON UIBC/TIBC ASSAY | Somas Medical Industries, Inc. | 1984-03-12 | Traditional | PDF ↗ |
| K834396 | DIRECT IRON REAGENT SET | Seragen Diagnostics, Inc. | 1984-02-21 | Traditional | PDF ↗ |
| K830564 | FEB TEST | Wako Chemicals USA, Inc. | 1983-03-29 | Traditional | PDF ↗ |
| K820629 | CORNING 902 SODIUM POTASSIUM ANALYZER | Corning Medical & Scientific | 1982-03-25 | Traditional | PDF ↗ |
| K810085 | IRON KIT | Bio-Analytics Laboratories, Inc. | 1981-01-28 | Traditional | PDF ↗ |
| K792406 | ELVI SERUM IRON | Volu Sol Medical Industries | 1979-12-07 | Traditional | PDF ↗ |
Product code CFM · Class I · Clinical Chemistry. Data: openFDA.