PREDICTA ERYTHROPOIETIN KIT (MODIFICATION)
FDA 510(k) clearance K954898 · decided 1996-02-05
Clearance details
- K-number
- K954898
- Device name
- PREDICTA ERYTHROPOIETIN KIT (MODIFICATION)
- Applicant
- Genzyme Corp.
- Decision
- Substantially Equivalent
- Date received
- 1995-09-20
- Decision date
- 1996-02-05
- Days to decision
- 138 days
- Clearance type
- Traditional
- Product code
- GGT
- Device class
- 2
- Regulation number
- 864.7250
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Cambridge, MA, US
- Third-party review
- No
- Expedited review
- No
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| 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 |
| 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 |
| PREDICTA ERYTHROPOIETIN KIT (K926390) | Genzyme Corp. | 1993-06-25 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| LEGOO (P110003/S004) | Genzyme Corp. | 2014-03-26 |
| LEGOO (P110003/S003) | Genzyme Corp. | 2012-11-13 |
| LEGOO ENDOVASCULAR OCCLUSION GEL (P110003/S002) | Genzyme Corp. | 2012-11-13 |
| LEGOO ENDOVASCULAR OCCLUDER (P110003/S001) | Genzyme Corp. | 2012-03-01 |
| LEGOO (P110003) | Genzyme Corp. | 2011-09-28 |
| FOCALSEAL-L SYNTHETIC ABSORBABLE SEALANT (P990028/S007) | Genzyme Corp. | 2003-12-04 |
| FOCALSEAL-L SYNTHETIC ABSORBABLE SEALANT (P990028/S006) | Genzyme Corp. | 2003-02-04 |
| FOCALSEAL-L SYNTHETIC ABSORBABLE SEALANT (P990028/S005) | Genzyme Corp. | 2002-11-25 |