EPO-RIA
FDA 510(k) clearance K910481 · decided 1991-11-29
Clearance details
- K-number
- K910481
- Device name
- EPO-RIA
- Applicant
- Ramco Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1991-02-06
- Decision date
- 1991-11-29
- Days to decision
- 296 days
- Clearance type
- Traditional
- Product code
- GGT
- Device class
- 2
- Regulation number
- 864.7250
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Houston, 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 |
|---|---|---|
| Access EPO (K240182) | Beckman Coulter, Inc. | 2024-04-22 |
| ADVIA Centaur Erythropoietin (EPO) assay (K183088) | Axis-Shield Diagnostics Limited | 2019-08-02 |
| ACCESS EPO ASSAY (K052223) | Beckman Coulter, Inc. | 2006-10-06 |
| SANGUI BIOTECH, INC. EPO (ERYTHROPOIETIN) ELISA KIT (K992799) | Sangui Biotech, Inc. | 2000-06-07 |
| IMMULITE EPO, MODEL #'S LKEPZ & LKEP1 (K983203) | Diagnostic Products Corp. | 1999-07-12 |
| ADVANTAGE CHEMILUMINESCENCE ERYTHROPOIETIN IMMUNOASSAY (K980737) | Nichols Institute Diagnostics | 1999-03-23 |
| ERYTHROPOIETIN IMMUNOASSAY KIT (K952559) | Nichols Institute | 1996-05-29 |
| PREDICTA ERYTHROPOIETIN KIT (MODIFICATION) (K954898) | Genzyme Corp. | 1996-02-05 |
| QUANTIKINE IVD ERYTHROPOIETIN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) (K936016) | R&D Systems, Inc. | 1994-07-19 |
| QUANTIKINE(TM) ERYTHROPOIETIN HUMAN SERUM CONTROLS (K931756) | R&D Systems, Inc. | 1994-04-21 |
| ERYTHROPOIETIN IMMUNOASSAY KIT (K932650) | Nichols Institute | 1994-03-11 |
| QUANTIKINE(TM) ERYTHROPOIETIN/ENZ LINK IMMUN ASSAY (K931666) | R&D Systems, Inc. | 1993-07-20 |
Recalls involving this device
No recalls on record reference this clearance.