The following data is part of a premarket notification filed by Streck, Inc with the FDA for Mdx-chex For Bcid2.
| Device ID | K212576 |
| 510k Number | K212576 |
| Device Name: | MDx-Chex For BCID2 |
| Classification | Assayed External Control Material For Microbiology Nucleic Acid Amplification (nat) Assays |
| Applicant | Streck, Inc 7002 S. 109th Street La Vista, NE 68128 |
| Contact | Deborah S. Kipp |
| Correspondent | Deborah S. Kipp Streck, Inc 7002 S. 109th Street La Vista, NE 68128 |
| Product Code | PMN |
| CFR Regulation Number | 866.3920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-08-16 |
| Decision Date | 2022-01-19 |