HER2 FISH PHARMDX KIT
FDA premarket approval P040005/S005 · decided 2010-10-20
Approval details
- PMA number
- P040005
- Supplement
- S005
- Supplement type
- Panel Track
- Trade name
- HER2 FISH PHARMDX KIT
- Generic name
- SYSTEM, TEST, HER-2/NEU, NUCLEIC ACID OR SERUM
- Applicant
- Agilent Technologies Singapore (International) Pte , Ltd.
- Date received
- 2010-04-20
- Decision date
- 2010-10-20
- Days to decision
- 183 days
- Decision code
- APPR
- Product code
- MVD
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Singapore
- Statement
- APPROVAL FOR THE HER2 FISH PHARMDX KIT. THE DEVICE IS INDICATED FOR IN VITRO DIAGNOSTIC USE. THE HER2 FISH PHARMDX KIT IS A DIRECT FLUORESCENCE IN SITU HYBRIDIZATION (FISH) ASSAY DESIGNED TO QUANTITATIVELY DETERMINE HER2 GENE AMPLIFICATION IN FORMALIN-FIXED, PARAFFIN-EMBEDDED (FFPE) BREAST CANCER TISSUE SPECIMENS AND FFPE SPECIMENS FROM PATIENTS WITH METASTATIC GASTRIC OR GASTROESOPHAGEAL JUNCTION ADENOCARCINOMA. HER2 FISH PHARMDX KIT IS INDICATED AS AN AID IN THE ASSESSMENT OF PATIENTS FOR WHOM
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