SPOT-LIGHT HER2 CISH KIT
FDA premarket approval P050040/S003 · decided 2012-07-06
Approval details
- PMA number
- P050040
- Supplement
- S003
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- 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
- 2012-06-01
- Decision date
- 2012-07-06
- Days to decision
- 35 days
- Decision code
- OK30
- Product code
- NYQ
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Grand Island, NY
- Statement
- EXTENSION OF THE EXPIRATION DATE FOR A SINGLE LOT OF HER-2 SPT DNA TEMPLATE (LOT 63013).
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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 |