Tumorlocalizer MRI
FDA 510(k) K962615 · Ferguson Medical
510(k) numberK962615
Submission
- Device name
- Tumorlocalizer MRI
- Applicant
- Ferguson Medical
Chico, CA, US - Received
- July 3, 1996
- Decision date
- March 19, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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 |
|---|---|---|---|
| K912888 | Uritec Test Strip & Human Urine + & - Test ControlMIG · Traditional | Dynagen, Inc. | 02/24/1992SE |
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Questions and answers
When was Tumorlocalizer MRI cleared by the FDA?
Tumorlocalizer MRI (K962615) received a 510(k) decision of Substantially Equivalent on March 19, 1998, 624 days after the submission was received.
What is the product code of K962615?
The FDA product code is MIG – Strip, Test Isoniazid, a Unclassified device.