Alere NMP22 BladderChek Test
FDA premarket approval P940035/S016 · decided 2021-06-15
Approval details
- PMA number
- P940035
- Supplement
- S016
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Alere NMP22 BladderChek Test
- Generic name
- System, test, tumor marker, for detection of bladder cancer
- Applicant
- Abbott Diagnostics Scarborough, Inc.
- Date received
- 2021-05-27
- Decision date
- 2021-06-15
- Days to decision
- 19 days
- Decision code
- OK30
- Product code
- NAH
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Scarborough, ME
- Statement
- New vendor for the resin contained in the nitrocellulose membrane.
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|---|---|---|
| BinaxNOW COVID-19 Ag Card (K250273) | Abbott Diagnostics Scarborough, Inc. | 2025-06-13 |
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| 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 |