510(k) K984119
- Device
- WAKO L-TYPE FE, WAKO L-TYPE CALIBRATOR
- Applicant
- WAKO CHEMICALS, USA, INC.
- 510(k) number
- K984119
- Product code
- CFM
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1999-01-15
- Date received
- 1998-11-18
- Regulation
- 862.1410
- Classification name
- Bathophenanthroline, Colorimetry, Iron (non-heme)
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- TONYA MALLORY
- Address
- 1600 Bellwood Rd. Richmond VA US 23237 23237
FDA Registration Numbers#
- 3003593973
- 3014325803
- 3003741796
- 1181121
Source Documents#
Other 510(k) Records For Product Code CFM #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K981581 | IRON | Abbott Laboratories | 1998-06-08 |
| K932871 | UIBC FOR DISCREET RANDOM ACCESS ANALYZER | Catachem, Inc. | 1993-09-08 |
| K913705 | ABBOTT QLUICKSTART IRON TEST, ITEM #5A29 | Em Diagnostic Systems, Inc. | 1991-10-09 |
| K912912 | SYNERMED SERUM IRON-600 REAGENT KIT | Synermed, Inc. | 1991-07-30 |
| K902918 | SYNERMED SERUM IRON REAGENT KIT | Synermed, Inc. | 1990-07-31 |
| K895047 | CLINISTAT POTASSIUM REAGENT TEST | Heraeus Kulzer, Inc. | 1989-10-17 |
| K891155 | IRON REAGENT | Medical Analysis Systems, Inc. | 1989-04-18 |
| K873120 | ABBOTT A-GENT IRON REAGENT KIT | Abbott Laboratories | 1987-08-25 |
| K861602 | TOTAL IRON BINDING CAPACITY PROCEDURE | Data Medical Associates, Inc. | 1986-05-23 |
| K854305 | DART IRON & IRON BINDING CAPACITY REAGENT | Coulter Electronics, Inc. | 1985-11-12 |
| K852583 | DATA CHEM IRON PROCEDURE | Data Medical Associates, Inc. | 1985-07-12 |
| K842505 | TDX REA IRON DIAGNOSTIC KIT | Abbott Laboratories | 1984-08-07 |
| K842156 | SERUM IRON & SERUM IRON BINDING CAPACITY | Diagnostic Chemicals, Ltd. (Usa) | 1984-08-07 |
| K842155 | SERUM IRON & SERUM IRON BINDING CAPACI | Diagnostic Chemicals, Ltd. (Usa) | 1984-08-07 |
| K840485 | TOTAL IRON UIBC/TIBC ASSAY | Somas Medical Industries, Inc. | 1984-03-12 |
Legacy Summary#
summary
FDA Review#
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