The following data is part of a premarket notification filed by Pasco Laboratories, Inc. with the FDA for Pasco Gram Negative Identification System.
| Device ID | K851528 |
| 510k Number | K851528 |
| Device Name: | PASCO GRAM NEGATIVE IDENTIFICATION SYSTEM |
| Classification | Gram Negative Identification Panel |
| Applicant | PASCO LABORATORIES, INC. 12750 WEST 42ND AVE. Wheat Ridge, CO 80033 |
| Contact | Linda K Dillon |
| Correspondent | Linda K Dillon PASCO LABORATORIES, INC. 12750 WEST 42ND AVE. Wheat Ridge, CO 80033 |
| Product Code | LQM |
| CFR Regulation Number | 866.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-04-18 |
| Decision Date | 1985-07-15 |