The following data is part of a premarket notification filed by Dade Intl., Inc. with the FDA for Dried Gram-negative And Gram-positive Mic/combo Panels.
| Device ID | K962150 |
| 510k Number | K962150 |
| Device Name: | DRIED GRAM-NEGATIVE AND GRAM-POSITIVE MIC/COMBO PANELS |
| Classification | Panels, Test, Susceptibility, Antimicrobial |
| Applicant | DADE INTL., INC. 1584 ENTERPRISE BLVD. West Sacramento,, CA 95691 |
| Contact | Sharon Cullen |
| Correspondent | Sharon Cullen DADE INTL., 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 | 1996-06-04 |
| Decision Date | 1996-08-16 |
| Summary: | summary |