PMA P050040S003
- Device
- SPOT-LIGHT HER2 CISH KIT
- Applicant
- Invitrogen Corporation
- PMA number
- P050040
- Supplement
- S003
- Product code
- NYQ
- Decision date
- 2012-07-06
- Generic name
- Chromogenic in situ hybridization, nucleic acid amplification, HER2/NEU gene, breast cancer
- Approval order statement
- EXTENSION OF THE EXPIRATION DATE FOR A SINGLE LOT OF HER-2 SPT DNA TEMPLATE (LOT 63013).
Current openFDA PMA Record#
- Device
- SPOT-LIGHT HER2 CISH KIT
- Applicant
- Invitrogen Corporation
- PMA number
- P050040
- Supplement
- S003
- Product code
- NYQ
- Generic name
- Chromogenic in situ hybridization, nucleic acid amplification, HER2/NEU gene, breast cancer
- Decision date
- 2012-07-06
- Decision code
- OK30
- Date received
- 2012-06-01
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- EXTENSION OF THE EXPIRATION DATE FOR A SINGLE LOT OF HER-2 SPT DNA TEMPLATE (LOT 63013).