The following data is part of a premarket notification filed by Dade Behring, Inc. with the FDA for Microscan Microstrep Plus Panel Cefuroxime (0.12-8 Mcg/ml).
| Device ID | K063053 |
| 510k Number | K063053 |
| Device Name: | MICROSCAN MICROSTREP PLUS PANEL CEFUROXIME (0.12-8 MCG/ML) |
| Classification | Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems |
| Applicant | DADE BEHRING, INC. 2040 ENTERPRISE BLVD. West Sacramento, CA 95691 |
| Contact | Shannon Popson |
| Correspondent | Shannon Popson DADE BEHRING, INC. 2040 ENTERPRISE BLVD. West Sacramento, CA 95691 |
| Product Code | LRG |
| CFR Regulation Number | 866.1640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-10-04 |
| Decision Date | 2006-10-26 |
| Summary: | summary |