The following data is part of a premarket notification filed by Mackeen Consultants, Ltd. with the FDA for Lactoplate.
| Device ID | K852737 |
| 510k Number | K852737 |
| Device Name: | LACTOPLATE |
| Classification | Lactoferrin, Antigen, Antiserum, Control |
| Applicant | MACKEEN CONSULTANTS, LTD. 4903 SANGAMORE RD. Bethesda, MD 20816 |
| Contact | Lewis Mackeen |
| Correspondent | Lewis Mackeen MACKEEN CONSULTANTS, LTD. 4903 SANGAMORE RD. Bethesda, MD 20816 |
| Product Code | DEG |
| CFR Regulation Number | 866.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-06-27 |
| Decision Date | 1985-10-25 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() LACTOPLATE 73520136 1391226 Dead/Cancelled |
JANSSEN, P.T. MR. 1985-01-31 |