The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics, Inc. with the FDA for Microscan(r) Microstrep Plus(r).
| Device ID | K111677 |
| 510k Number | K111677 |
| Device Name: | MICROSCAN(R) MICROSTREP PLUS(R) |
| Classification | Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems |
| Applicant | SIEMENS HEALTHCARE DIAGNOSTICS, INC. 1584 ENTERPRISE BLVD. West Sacramento, CA 95691 |
| Contact | Jenifer Dawson Driscoll |
| Correspondent | Jenifer Dawson Driscoll 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 | 2011-06-15 |
| Decision Date | 2011-08-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15099590655754 | K111677 | 000 |