The following data is part of a premarket notification filed by Meloy Laboratories, Inc. with the FDA for Human Igg-albumin Test Kit.
| Device ID | K811178 |
| 510k Number | K811178 |
| Device Name: | HUMAN IGG-ALBUMIN TEST KIT |
| Classification | Radial Immunodiffusion, Albumin |
| Applicant | MELOY LABORATORIES, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | CJQ |
| CFR Regulation Number | 862.1035 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-04-28 |
| Decision Date | 1981-05-15 |