The following data is part of a premarket notification filed by Lab Ability, Inc. with the FDA for Shigella Sera-chek.
| Device ID | K813191 |
| 510k Number | K813191 |
| Device Name: | SHIGELLA SERA-CHEK |
| Classification | Antigens, All Groups, Shigella Spp. |
| Applicant | LAB ABILITY, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | LIA |
| CFR Regulation Number | 866.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-11-17 |
| Decision Date | 1981-12-03 |