The following data is part of a premarket notification filed by Lab Ability, Inc. with the FDA for Q-check Reagent Standards.
| Device ID | K830134 |
| 510k Number | K830134 |
| Device Name: | Q-CHECK REAGENT STANDARDS |
| Classification | Quality Control Slides |
| Applicant | LAB ABILITY, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | LJG |
| CFR Regulation Number | 866.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-01-09 |
| Decision Date | 1983-01-09 |