SPOT-LIGHT HER2 CISH KIT
FDA premarket approval P050040/S002 · decided 2011-04-29
Approval details
- PMA number
- P050040
- Supplement
- S002
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- SPOT-LIGHT HER2 CISH KIT
- Generic name
- Chromogenic in situ hybridization, nucleic acid amplification, HER2/NEU gene, breast cancer
- Applicant
- Invitrogen Corporation
- Date received
- 2011-03-01
- Decision date
- 2011-04-29
- Days to decision
- 59 days
- Decision code
- APPR
- Product code
- NYQ
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Grand Island, NY
- Statement
- APPROVAL FOR CHANGES IN THE PRODUCT INSERT: 1) MANUFACTURING ADDRESS CHANGE; 2) COPYRIGHT CHANGE FROM INVITROGEN CORPORATION TO LIFE TECHNOLOGIES. INVITROGEN WILL REMAIN THE BRAND NAME AND THEREFORE IS STILL INCLUDED ON THE PRODUCT INSERT AND LABELING; AND AN ADDITION OF LITERATURE REFERENCES TO THE BIBLIOGRAPHY.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| AIM-V (R) MEDIUM, MODEL 087-0112 (K022086) | Invitrogen Corporation | 2002-12-23 |