HER2 IQFISH PHARMDX
FDA premarket approval P040005/S010 · decided 2013-08-28
Approval details
- PMA number
- P040005
- Supplement
- S010
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- HER2 IQFISH PHARMDX
- Generic name
- SYSTEM, TEST, HER-2/NEU, NUCLEIC ACID OR SERUM
- Applicant
- Agilent Technologies Singapore (International) Pte , Ltd.
- Date received
- 2013-08-01
- Decision date
- 2013-08-28
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- MVD
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Singapore
- Statement
- ADDITIONAL PROBE DNA LABELING OPTION FOR LABELING DNA POOLS.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.