510(k) K071712
- Device
- LEUKO EZ VUE
- Applicant
- TECHLAB INC., CORPORATE RESEARCH CENTER
- 510(k) number
- K071712
- Product code
- DEG
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2007-12-04
- Date received
- 2007-06-22
- Regulation
- 866.5570
- Classification name
- Lactoferrin, Antigen, Antiserum, Control
- Medical specialty
- Immunology
- Review panel
- Immunology
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- CHARLES PENNINGTON
- Address
- 2001 Kraft Dr. Blacksburg VA US 24060 24060
FDA Registration Numbers#
- 3002800697
- 3005360469
- 1222302
- 3009935129
- 3024463179
- 1122855
- 2245285
- 3042167929
- 2032839
- 3031915160
Source Documents#
Other 510(k) Records For Product Code DEG #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K852737 | LACTOPLATE | Mackeen Consultants, Ltd. | 1985-10-25 |
Legacy Summary#
summary
FDA Review#
Decision Summary