The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics Products Gmbh with the FDA for N Latex Flc Kappa Assay, N Latex Flc Lambda Assay, N Flc Standard Sl, N Flc Control Sl1 & Sl2.
| Device ID | K171742 |
| 510k Number | K171742 |
| Device Name: | N Latex FLC Kappa Assay, N Latex FLC Lambda Assay, N FLC Standard SL, N FLC Control SL1 & SL2 |
| Classification | Kappa, Antigen, Antiserum, Control |
| Applicant | Siemens Healthcare Diagnostics Products GmbH Emil-von-Behring-Str. 76 Marburg, DE 35041 |
| Contact | Christine Perkins |
| Correspondent | Christine Perkins Siemens Healthcare Diagnostics Products GmbH Emil-von-Behring-Str. 76 Marburg, DE 35041 |
| Product Code | DFH |
| CFR Regulation Number | 866.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-06-12 |
| Decision Date | 2017-11-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414237503 | K171742 | 000 |
| 00630414237497 | K171742 | 000 |
| 00630414237480 | K171742 | 000 |
| 00630414237473 | K171742 | 000 |
| 00842768031465 | K171742 | 000 |
| 00842768031458 | K171742 | 000 |
| 00842768031441 | K171742 | 000 |
| 00842768031434 | K171742 | 000 |