510(k) K852737
- Device
- LACTOPLATE
- Applicant
- MACKEEN CONSULTANTS, LTD.
- 510(k) number
- K852737
- Product code
- DEG
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1985-10-25
- Date received
- 1985-06-27
- Regulation
- 866.5570
- Classification name
- Lactoferrin, Antigen, Antiserum, Control
- Medical specialty
- Immunology
- Review panel
- Immunology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- LEWIS MACKEEN
- Address
- 4903 Sangamore Rd. Bethesda MD US 20816 20816
FDA Registration Numbers#
- 3005360469
- 3002800697
- 2032839
- 3031915160
- 3009935129
- 1222302
- 3024463179
- 2245285
- 1122855
- 3042167929
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code DEG #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K071712 | LEUKO EZ VUE | Techlab Inc., Corporate Research Center | 2007-12-04 |
| K042071 | IBD-SCAN | Techlab, Inc. | 2004-10-20 |
| K030704 | IBD-QUIK CHEK | Techlab, Inc. | 2003-04-21 |
| K011396 | IBD-CHEK | Techlab, Inc. | 2001-06-18 |
| K951101 | LEUKO-TEST | Techlab, Inc. | 1995-04-24 |
| K934473 | LACTOFERRIN MICROASSAY SYSTEM | Touch Scientific, Inc. | 1993-12-03 |
| K931901 | LACTOCARD | Touch Scientific, Inc. | 1993-07-06 |
Legacy Summary#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases