The following data is part of a premarket notification filed by Dade Microscan, Inc. with the FDA for Dried Gram-positive Mic/combo Panels.
| Device ID | K003619 |
| 510k Number | K003619 |
| Device Name: | DRIED GRAM-POSITIVE MIC/COMBO PANELS |
| Classification | Panels, Test, Susceptibility, Antimicrobial |
| Applicant | DADE MICROSCAN, INC. 1584 ENTERPRISE BLVD. West Sacramento, CA 95691 |
| Contact | Cynthia Van Duker |
| Correspondent | Cynthia Van Duker DADE MICROSCAN, INC. 1584 ENTERPRISE BLVD. West Sacramento, CA 95691 |
| Product Code | LTT |
| CFR Regulation Number | 866.1640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-11-22 |
| Decision Date | 2001-01-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15099590704049 | K003619 | 000 |
| 15099590657550 | K003619 | 000 |
| 15099590657536 | K003619 | 000 |
| 15099590657512 | K003619 | 000 |