The following data is part of a premarket notification filed by Dade Behring, Inc. with the FDA for Microscan Dried Gram Negative Mic/combo Panels Amoxicillin/k. Clavulanate.
| Device ID | K050585 |
| 510k Number | K050585 |
| Device Name: | MICROSCAN DRIED GRAM NEGATIVE MIC/COMBO PANELS AMOXICILLIN/K. CLAVULANATE |
| Classification | Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems |
| Applicant | DADE BEHRING, INC. 2040 ENTERPRISE BLVD. West Sacramento, CA 95691 |
| Contact | Robert Eusebio |
| Correspondent | Robert Eusebio DADE BEHRING, INC. 2040 ENTERPRISE BLVD. West Sacramento, CA 95691 |
| Product Code | LRG |
| CFR Regulation Number | 866.1640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-03-07 |
| Decision Date | 2005-03-18 |