510(k) K023824
- Device
- ALBUMIN COBALT BINDING TEST (ACB TEST)
- Applicant
- ISCHEMIA TECHNOLOGIES, INC.
- 510(k) number
- K023824
- Product code
- NJV
- Decision
- Se - With Limitations (SESU)
- Decision date
- 2003-02-14
- Date received
- 2002-11-18
- Regulation
- 862.1215
- Classification name
- Test, Albumin Cobalt Binding
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- PETER CROSBY
- Address
- 4600 W. 60th Ave. Denver CO US 80003 80003
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code NJV #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K053196 | ISCHEMIA ALBUMIN COBALT BINDING TEST (ACB TEST) | Inverness Medical Innovations, Inc. | 2005-12-16 |
Legacy Summary#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases