EPO-TRAC BY RADIOIMMUNOASSAY (RIA)
FDA 510(k) clearance K893393 · decided 1989-11-21
Clearance details
- K-number
- K893393
- Device name
- EPO-TRAC BY RADIOIMMUNOASSAY (RIA)
- Applicant
- Incstar Corp.
- Decision
- Substantially Equivalent
- Date received
- 1989-05-01
- Decision date
- 1989-11-21
- Days to decision
- 204 days
- Clearance type
- Traditional
- Product code
- GGT
- Device class
- 2
- Regulation number
- 864.7250
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Stillwater, MN, US
- Third-party review
- No
- Expedited review
- No
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| 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.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| CLINICAL ASSAYS (TM) GAMMADAB(R) [ 125 I ] (P790032/S003) | Incstar Corp. | 1993-07-23 |
| CLINICAL ASSAYS (TM) GAMMADAB(R) [ 125 I ] (P790032/S002) | Incstar Corp. | 1991-03-28 |
| GAMMA DAB (125I) AFP RIA KIT (P790032/S001) | Incstar Corp. | 1986-08-22 |
| GAMMA DAB (125I) AFP RIA KIT (P790032) | Incstar Corp. | 1986-04-30 |