The following data is part of a premarket notification filed by Pasco Laboratories, Inc. with the FDA for Till-u-test G.c. Gonococus Slide.
| Device ID | K831268 |
| 510k Number | K831268 |
| Device Name: | TILL-U-TEST G.C. GONOCOCUS SLIDE |
| Classification | Culture Media, For Isolation Of Pathogenic Neisseria |
| Applicant | PASCO LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JTY |
| CFR Regulation Number | 866.2410 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-04-18 |
| Decision Date | 1983-05-13 |