The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics Inc. with the FDA for Atellica Im Folate Assay.
| Device ID | K172201 |
| 510k Number | K172201 |
| Device Name: | Atellica IM Folate Assay |
| Classification | Acid, Folic, Radioimmunoassay |
| Applicant | Siemens Healthcare Diagnostics Inc. 511 Benedict Avenue Tarrytown, NY 10591 |
| Contact | Darius Daruwala |
| Correspondent | Darius Daruwala Siemens Healthcare Diagnostics Inc. 511 Benedict Avenue Tarrytown, NY 10591 |
| Product Code | CGN |
| CFR Regulation Number | 862.1295 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-07-21 |
| Decision Date | 2018-04-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414599007 | K172201 | 000 |
| 00630414598994 | K172201 | 000 |
| 00630414598987 | K172201 | 000 |
| 00630414598970 | K172201 | 000 |
| 00630414598963 | K172201 | 000 |
| 00630414597690 | K172201 | 000 |
| 00630414293653 | K172201 | 000 |