AIM-V (R) MEDIUM, MODEL 087-0112
FDA 510(k) clearance K022086 · decided 2002-12-23
Clearance details
- K-number
- K022086
- Device name
- AIM-V (R) MEDIUM, MODEL 087-0112
- Applicant
- Invitrogen Corporation
- Decision
- Substantially Equivalent
- Date received
- 2002-06-27
- Decision date
- 2002-12-23
- Days to decision
- 179 days
- Clearance type
- Traditional
- Product code
- NDS
- Device class
- 2
- Regulation number
- 876.5885
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Grand Island, NY, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
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PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| SPOT-LIGHT HER2 CISH KIT (P050040/S003) | Invitrogen Corporation | 2012-07-06 |
| SPOT-LIGHT HER2 CISH KIT (P050040/S001) | Invitrogen Corporation | 2011-07-12 |
| SPOT-LIGHT HER2 CISH KIT (P050040/S002) | Invitrogen Corporation | 2011-04-29 |
| SPOT-LIGHT HER2 CISH KIT (P050040) | Invitrogen Corporation | 2008-07-01 |