Leuko Ez Vue
FDA 510(k) K071712 · Techlab Inc., Corporate Research Center
510(k) numberK071712
Submission
- Device name
- Leuko Ez Vue
- Applicant
- Techlab Inc., Corporate Research Center
Blacksburg, VA, US - Received
- June 22, 2007
- Decision date
- December 4, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DEG – Lactoferrin, Antigen, Antiserum, Control
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.5570
- Specialty
- Immunology
Other 510(k)s with product code DEG
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K042071 | Ibd-ScanDEG · Traditional | Techlab, Inc. | 10/20/2004SE |
| K030704 | Ibd-Quik ChekDEG · Traditional | Techlab, Inc. | 04/21/2003SE |
| K011396 | Ibd-ChekDEG · Traditional | Techlab, Inc. | 06/18/2001SE |
| K951101 | Leuko-TestDEG · Traditional | Techlab, Inc. | 04/24/1995SE |
| K934473 | Lactoferrin Microassay SystemDEG · Traditional | Touch Scientific, Inc. | 12/03/1993SE |
| K931901 | LactocardDEG · Traditional | Touch Scientific, Inc. | 07/06/1993SE |
| K852737 | LactoplateDEG · Traditional | Mackeen Consultants, Ltd. | 10/25/1985SE |
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Questions and answers
When was Leuko Ez Vue cleared by the FDA?
Leuko Ez Vue (K071712) received a 510(k) decision of Substantially Equivalent on December 4, 2007, 165 days after the submission was received.
What is the product code of K071712?
The FDA product code is DEG – Lactoferrin, Antigen, Antiserum, Control, a Class I (low risk) device regulated under 21 CFR 866.5570.