The following data is part of a premarket notification filed by Nanogen, Inc. with the FDA for Statusfirst Chf (congestive Heart Failure) Nt-probnp, Model 20204.
| Device ID | K051596 |
| 510k Number | K051596 |
| Device Name: | STATUSFIRST CHF (CONGESTIVE HEART FAILURE) NT-PROBNP, MODEL 20204 |
| Classification | Test, Natriuretic Peptide |
| Applicant | NANOGEN, INC. 10398 PACIFIC CENTER CT. San Diego, CA 92121 -4340 |
| Contact | Van N Schramm |
| Correspondent | Van N Schramm NANOGEN, INC. 10398 PACIFIC CENTER CT. San Diego, CA 92121 -4340 |
| Product Code | NBC |
| CFR Regulation Number | 862.1117 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-06-16 |
| Decision Date | 2006-03-13 |
| Summary: | summary |