NMP22 BLADDERCHEK TEST KIT
FDA premarket approval P940035/S003 · decided 2003-04-25
Approval details
- PMA number
- P940035
- Supplement
- S003
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- NMP22 BLADDERCHEK TEST KIT
- Generic name
- System, test, tumor marker, for detection of bladder cancer
- Applicant
- Abbott Diagnostics Scarborough, Inc.
- Date received
- 2002-09-16
- Decision date
- 2003-04-25
- Days to decision
- 221 days
- Decision code
- APPR
- Product code
- NAH
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Scarborough, ME
- Statement
- APPROVAL FOR NEW TEST FORMAT TO BE MANUFACTURED AT MATRITECH, INC., NEWTON, MASSACHUSETTS AND AT A NEW FACILITY, UNOTECH DIAGNOSTICS, INC., SAN LEANDRO, CALIFORNIA. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME NMP22 BLADDERCHEK KIT AND IS INDICATED FOR THE FOLLOWING: THE MATRITECH NMP22 BLADDERCHEK TEST IS AN IN VITRO IMMUNOASSAY INTENDED FOR THE QUALITATIVE DETECTION OF NMP22 NUCLEAR MATRIX PROTEIN IN URINE OF PERSONS WITH RISK FACTORS OR SYMPTOMS OF BLADDER CANCER OR WITH A H
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
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 |