NMP22 BladderChek Test
FDA premarket approval P940035/S017 · decided 2022-07-12
Approval details
- PMA number
- P940035
- Supplement
- S017
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- NMP22 BladderChek Test
- Generic name
- System, test, tumor marker, for detection of bladder cancer
- Applicant
- Abbott Diagnostics Scarborough, Inc.
- Date received
- 2022-02-08
- Decision date
- 2022-07-12
- Days to decision
- 154 days
- Decision code
- APPR
- Product code
- NAH
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Scarborough, ME
- Statement
- Approval to manufacture Alere NMP22 BladderChek Test under Abbott Diagnostics Scarborough, Inc.s new brand name: NMP22 BladderChek Test.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| BinaxNOW COVID-19 Ag Card (K250273) | Abbott Diagnostics Scarborough, Inc. | 2025-06-13 |
| BinaxNOW™ COVID-19 Antigen Self Test (K243518) | Abbott Diagnostics Scarborough, Inc. | 2025-02-11 |
| ID NOW Influenza A & B 2 (K232775) | Abbott Diagnostics Scarborough, Inc. | 2023-10-10 |
| ID NOW COVID-19 2.0 (K221925) | Abbott Diagnostics Scarborough, Inc. | 2023-08-10 |
| ID Now Instrument, ID Now Influenza A & B 2, ID NOW Strep A 2 (K220801) | Abbott Diagnostics Scarborough, Inc. | 2022-06-24 |
| ID NOW Influenza A & B 2 (K191534) | Abbott Diagnostics Scarborough, Inc. | 2019-07-11 |