The following data is part of a premarket notification filed by Cnr Labs with the FDA for Microdilution Gram-negative Id. Panel.
| Device ID | K781368 |
| 510k Number | K781368 |
| Device Name: | MICRODILUTION GRAM-NEGATIVE ID. PANEL |
| Classification | Kit, Identification, Enterobacteriaceae |
| Applicant | CNR LABS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JSS |
| CFR Regulation Number | 866.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-08-08 |
| Decision Date | 1978-10-03 |