RealTime IDH1
FDA premarket approval P170041/S001 · decided 2019-09-24
Approval details
- PMA number
- P170041
- Supplement
- S001
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- RealTime IDH1
- Generic name
- Somatic gene mutation detection system
- Applicant
- Abbott Molecular, Inc.
- Date received
- 2019-08-29
- Decision date
- 2019-09-24
- Days to decision
- 26 days
- Decision code
- OK30
- Product code
- OWD
- Advisory committee
- Medical Genetics
- Expedited review
- No
- Location
- Des Plaines, IL
- Statement
- Additional internal QC testing for the DNA Sample Preparation Kit.
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510(k) clearances by this applicant
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| Alinity m HCV (K252102) | Abbott Molecular, Inc. | 2025-09-25 |
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| Alinity m CMV (K243485) | Abbott Molecular, Inc. | 2025-07-01 |
| Alinity m BKV (K241921) | Abbott Molecular, Inc. | 2025-03-24 |
| Alinity m Resp-4-Plex (K241573) | Abbott Molecular, Inc. | 2025-02-14 |
| Alinity m HSV 1 & 2 / VZV (K233349) | Abbott Molecular, Inc. | 2024-05-03 |
| Alinity m STI Assay (K222379) | Abbott Molecular, Inc. | 2023-03-03 |
| Alinity m EBV AMP Kit (List No. 09N43-095), Alinity m EBV CTRL Kit (List No. 09N43-085), Alinity m EBV CAL Kit (List No. 09N43-075) (K212778) | Abbott Molecular, Inc. | 2022-07-15 |