510(k) K912888
- Device
- URITEC TEST STRIP & HUMAN URINE + & - TEST CONTROL
- Applicant
- DYNAGEN, INC.
- 510(k) number
- K912888
- Product code
- MIG
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1992-02-24
- Date received
- 1991-07-01
- Regulation
- 510(k) Premarket Notification
- Classification name
- Strip, Test Isoniazid
- Medical specialty
- 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices
- Review panel
- Toxicology
- Device class
- U
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- PETER J MIONE
- Address
- 99 Erie St., Cambridge MA US 02139 02139
FDA Registration Numbers#
- 3000126629
- 3009077524
- 1054811
- 3009656988
- 2029275
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code MIG #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K962615 | TUMORLOCALIZER MRI | Ferguson Medical | 1998-03-19 |
Legacy Summary#
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FDA Review#
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