ABBOTT A-GENT IRON REAGENT KIT
FDA 510(k) clearance K873120 · decided 1987-08-25
Clearance details
- K-number
- K873120
- Device name
- ABBOTT A-GENT IRON REAGENT KIT
- Applicant
- Abbott Laboratories
- Decision
- Substantially Equivalent
- Date received
- 1987-08-10
- Decision date
- 1987-08-25
- Days to decision
- 15 days
- Clearance type
- Traditional
- Product code
- CFM
- Device class
- 1
- Regulation number
- 862.1410
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Irving, TX, US
- Third-party review
- No
- Expedited review
- No
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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 |
| 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 |
| DATA CHEM IRON PROCEDURE (K852583) | Data Medical Associates, Inc. | 1985-07-12 |
| 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.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| ARCHITECT CORE / Alinity i Anti-HBc (P080023/S046) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT AFP / Alinity i AFP (P120008/S030) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT CORE-M / Alinity i Anti-HBc IgM (P060035/S043) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT Total PSA / Alinity i Total PSA (P910007/S066) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT Free PSA / Alinity i Free PSA (P980007/S055) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT HBsAg Qualitative/Qualitative Confirmatory / Alinity i HBsAg Qualitative II/Qualitative II Confirmatory (P110029/S052) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT HBsAg Next Qualitative / ARCHITECT HBsAg Next Confirmatory/ Alinity i HBsAg Next Qualitative/Alinity i HBsAg N (P210003/S013) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT HBsAg Next Qualitative/Next Confirmatory, Alinity i HBsAg Next Qualitative/Next Confirmatory (P210003/S012) | Abbott Laboratories | 2024-09-30 |