PMA P050040S001
- Device
- SPOT-LIGHT HER2 CISH KIT
- Applicant
- Invitrogen Corporation
- PMA number
- P050040
- Supplement
- S001
- Product code
- NYQ
- Decision date
- 2011-07-12
- Generic name
- Chromogenic in situ hybridization, nucleic acid amplification, HER2/NEU gene, breast cancer
- Approval order statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED IN FREDERICK, MARYLAND.
Current openFDA PMA Record#
- Device
- SPOT-LIGHT HER2 CISH KIT
- Applicant
- Invitrogen Corporation
- PMA number
- P050040
- Supplement
- S001
- Product code
- NYQ
- Generic name
- Chromogenic in situ hybridization, nucleic acid amplification, HER2/NEU gene, breast cancer
- Decision date
- 2011-07-12
- Decision code
- APPR
- Date received
- 2011-02-03
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED IN FREDERICK, MARYLAND.