VITROS Anti-HBe
FDA premarket approval P100001/S016 · decided 2019-06-19
Approval details
- PMA number
- P100001
- Supplement
- S016
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- VITROS Anti-HBe
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Applicant
- Ortho-Clinical Diagnostics
- Date received
- 2019-05-21
- Decision date
- 2019-06-19
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- LOM
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Rochester, NY
- Statement
- Establishment of a new Environmental Controlled Area Room at an existing facility.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| VITROS Immunodiagnostic Products Syphilis Reagent Pack (K241534) | Ortho Clinical Diagnostics | 2024-08-28 |
| VITROS Immunodiagnostic Products Total ß-hCG II Reagent Pack (K233581) | Ortho Clinical Diagnostics | 2024-05-08 |
| VITROS Immunodiagnostic Products Intact PTH II Reagent Pack (K221197) | Ortho Clinical Diagnostics | 2023-09-05 |
| VITROS Immunodiagnostic Products CEA Reagent Pack (K231517) | Ortho Clinical Diagnostics | 2023-08-23 |
| VITROS Immunodiagnostic Products CA 19-9TM Reagent Pack (K231525) | Ortho Clinical Diagnostics | 2023-08-09 |
| VITROS Immuodiagnostic Products CA 125 II Reagent Pack (K221355) | Ortho Clinical Diagnostics | 2022-12-12 |
| VITROS AFP (K213626) | Ortho Clinical Diagnostics | 2022-06-15 |
| VITROS Immunodiagnostic Products CK-MB Reagent Pack (K212648) | Ortho Clinical Diagnostics | 2022-01-28 |