Ibd-Quik Chek
FDA 510(k) K030704 · Techlab, Inc.
510(k) numberK030704
Submission
- Device name
- Ibd-Quik Chek
- Applicant
- Techlab, Inc.
Blacksburg, VA, US - Received
- March 6, 2003
- Decision date
- April 21, 2003
- 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 |
|---|---|---|---|
| K071712 | Leuko Ez VueDEG · Traditional | Techlab Inc., Corporate Research Center | 12/04/2007SE |
| K042071 | Ibd-ScanDEG · Traditional | Techlab, Inc. | 10/20/2004SE |
| 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 |
More from Mackeen Consultants, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K191456 | Campylobacter Quik ChekLQP · Special | 06/20/2019SE |
| K191442 | Campylobacter ChekLQP · Special | 06/20/2019SE |
| K181400 | H. Pylori ChekLYR · Traditional | 08/21/2018SE |
| K181379 | H. Pylori Quik ChekLYR · Traditional | 08/21/2018SE |
| K173219 | Campylobacter ChekLQP · Traditional | 01/22/2018SE |
| K173217 | Campylobacter Quik ChekLQP · Traditional | 01/22/2018SE |
| K171078 | Tri-Combo Parasite ScreenMHJ · Traditional | 07/10/2017SE |
| K170728 | E. Histolytica Quik ChekKHW · Traditional | 06/07/2017SE |
| K082499 | C. Diff Quik Chek CompleteLLH · Traditional | 03/26/2009SE |
| K053572 | C. Diff Quik ChekMCB · Traditional | 04/26/2006SE |
Questions and answers
When was Ibd-Quik Chek cleared by the FDA?
Ibd-Quik Chek (K030704) received a 510(k) decision of Substantially Equivalent on April 21, 2003, 46 days after the submission was received.
What is the product code of K030704?
The FDA product code is DEG – Lactoferrin, Antigen, Antiserum, Control, a Class I (low risk) device regulated under 21 CFR 866.5570.