The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics with the FDA for Microscan Microstrep Plus, Model B1027-201.
| Device ID | K091949 |
| 510k Number | K091949 |
| Device Name: | MICROSCAN MICROSTREP PLUS, MODEL B1027-201 |
| Classification | Panels, Test, Susceptibility, Antimicrobial |
| Applicant | SIEMENS HEALTHCARE DIAGNOSTICS 1584 ENTERPRISE BLVD West Sacramento, CA 95691 |
| Contact | Shannon Popson |
| Correspondent | Shannon Popson SIEMENS HEALTHCARE DIAGNOSTICS 1584 ENTERPRISE BLVD West Sacramento, CA 95691 |
| Product Code | LTT |
| CFR Regulation Number | 866.1640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-07-01 |
| Decision Date | 2010-01-26 |
| Summary: | summary |