The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics, Inc. with the FDA for Microscan (r) Microstrep Plus (r) Panels.
| Device ID | K111205 |
| 510k Number | K111205 |
| Device Name: | MICROSCAN (R) MICROSTREP PLUS (R) PANELS |
| Classification | Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems |
| Applicant | SIEMENS HEALTHCARE DIAGNOSTICS, INC. 1584 ENTERPRISE BLVD. West Sacramento, CA 95691 |
| Contact | Shannon Popson |
| Correspondent | Shannon Popson SIEMENS HEALTHCARE DIAGNOSTICS, INC. 1584 ENTERPRISE BLVD. West Sacramento, CA 95691 |
| Product Code | LRG |
| Subsequent Product Code | JWY |
| Subsequent Product Code | LTW |
| CFR Regulation Number | 866.1640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-04-29 |
| Decision Date | 2011-07-20 |
| Summary: | summary |