The following data is part of a premarket notification filed by Matritech, Inc. with the FDA for Nmp22 Bladderchek Kit, Nmp22 Control Kit.
| Device ID | K021231 |
| 510k Number | K021231 |
| Device Name: | NMP22 BLADDERCHEK KIT, NMP22 CONTROL KIT |
| Classification | System, Test, Tumor Marker, Monitoring, Bladder |
| Applicant | MATRITECH, INC. 330 NEVADA ST., 2ND FL. Newton, MA 02460 |
| Contact | Melodie R Domurad |
| Correspondent | Melodie R Domurad MATRITECH, INC. 330 NEVADA ST., 2ND FL. Newton, MA 02460 |
| Product Code | MMW |
| CFR Regulation Number | 866.6010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-04-18 |
| Decision Date | 2002-07-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00811877011552 | K021231 | 000 |
| 10811877010606 | K021231 | 000 |