The following data is part of a premarket notification filed by Immulok, Inc. with the FDA for H-101 Kappa,h-102 Lambda,h-107 Lysozme.
| Device ID | K811721 |
| 510k Number | K811721 |
| Device Name: | H-101 KAPPA,H-102 LAMBDA,H-107 LYSOZME |
| Classification | Kappa, Antigen, Antiserum, Control |
| Applicant | IMMULOK, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DFH |
| CFR Regulation Number | 866.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-06-18 |
| Decision Date | 1981-07-16 |