DATA CHEM IRON PROCEDURE
FDA 510(k) clearance K852583 · decided 1985-07-12
Clearance details
- K-number
- K852583
- Device name
- DATA CHEM IRON PROCEDURE
- Applicant
- Data Medical Associates, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1985-06-18
- Decision date
- 1985-07-12
- Days to decision
- 24 days
- Clearance type
- Traditional
- Product code
- CFM
- Device class
- 1
- Regulation number
- 862.1410
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Arlington, TX, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Data Medical Associates
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| WAKO L-TYPE FE, WAKO L-TYPE CALIBRATOR (K984119) | Wako Chemicals USA, Inc. | 1999-01-15 |
| IRON (K981581) | Abbott Laboratories | 1998-06-08 |
| UIBC FOR DISCREET RANDOM ACCESS ANALYZER (K932871) | Catachem, Inc. | 1993-09-08 |
| ABBOTT QLUICKSTART IRON TEST, ITEM #5A29 (K913705) | Em Diagnostic Systems, Inc. | 1991-10-09 |
| SYNERMED SERUM IRON-600 REAGENT KIT (K912912) | Synermed, Inc. | 1991-07-30 |
| SYNERMED SERUM IRON REAGENT KIT (K902918) | Synermed, Inc. | 1990-07-31 |
| CLINISTAT POTASSIUM REAGENT TEST (K895047) | Heraeus Kulzer, Inc. | 1989-10-17 |
| IRON REAGENT (K891155) | Medical Analysis Systems, Inc. | 1989-04-18 |
| ABBOTT A-GENT IRON REAGENT KIT (K873120) | Abbott Laboratories | 1987-08-25 |
| TOTAL IRON BINDING CAPACITY PROCEDURE (K861602) | Data Medical Associates, Inc. | 1986-05-23 |
| DART IRON & IRON BINDING CAPACITY REAGENT (K854305) | Coulter Electronics, Inc. | 1985-11-12 |
| SERUM IRON & SERUM IRON BINDING CAPACI (K842155) | Diagnostic Chemicals, Ltd. (Usa) | 1984-08-07 |
Recalls involving this device
No recalls on record reference this clearance.