The following data is part of a premarket notification filed by B.r.a.h.m.s Gmbh with the FDA for B R A H M S Pct Sensitive Kryptor.
| Device ID | K171338 |
| 510k Number | K171338 |
| Device Name: | B R A H M S PCT Sensitive KRYPTOR |
| Classification | Procalcitonin Assay |
| Applicant | B.R.A.H.M.S GmbH Neuendorfstr. 25 Hennigsdorf, DE 16761 |
| Contact | Sascha Johannes |
| Correspondent | Bernhard Ciommer B.R.A.H.M.S GmbH Neuendorfstr. 25 Hennigsdorf, DE 16761 |
| Product Code | PRI |
| Subsequent Product Code | NTM |
| Subsequent Product Code | PMT |
| CFR Regulation Number | 866.3215 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-05-08 |
| Decision Date | 2017-05-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04260157638259 | K171338 | 000 |