Uritec Test Strip & Human Urine + & - Test Control
FDA 510(k) K912888 · Dynagen, Inc.
510(k) numberK912888
Submission
- Device name
- Uritec Test Strip & Human Urine + & - Test Control
- Applicant
- Dynagen, Inc.
Cambridge, MA, US - Received
- July 1, 1991
- Decision date
- February 24, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- MIG – Strip, Test Isoniazid
- Device class
- Unclassified
Other 510(k)s with product code MIG
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K962615 | Tumorlocalizer MRIMIG · Traditional | Ferguson Medical | 03/19/1998SE |
More from Ferguson Medical
| 510(k) | Device | Decision |
|---|---|---|
| K963733 | Niccheck IMRS · Traditional | 12/13/1996SE |
| K943051 | Mycoakt M. Tuberculosis Cuulture Id KitJSY · Traditional | 03/13/1995SE |
| K943050 | Mycoakt M Kansasii Culture Id KitJSY · Traditional | 03/13/1995SE |
| K943049 | Mycoakt M. Avium Culture Id KitJSY · Traditional | 03/13/1995SE |
| K931105 | Procheck(Tm) Blind Performance SpecimensDIF · Traditional | 04/21/1993SE |
Questions and answers
When was Uritec Test Strip & Human Urine + & - Test Control cleared by the FDA?
Uritec Test Strip & Human Urine + & - Test Control (K912888) received a 510(k) decision of Substantially Equivalent on February 24, 1992, 238 days after the submission was received.
What is the product code of K912888?
The FDA product code is MIG – Strip, Test Isoniazid, a Unclassified device.