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 |