510(k) K053196
- Device
- ISCHEMIA ALBUMIN COBALT BINDING TEST (ACB TEST)
- Applicant
- INVERNESS MEDICAL INNOVATIONS, INC.
- 510(k) number
- K053196
- Product code
- NJV
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2005-12-16
- Date received
- 2005-11-16
- Regulation
- 862.1215
- Classification name
- Test, Albumin Cobalt Binding
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- JAMES M DELANEY
- Address
- 51 Sawyer Rd., Suite 200 Waltham MA US 02453 02453
Source Documents#
Other 510(k) Records For Product Code NJV #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K023824 | ALBUMIN COBALT BINDING TEST (ACB TEST) | Ischemia Technologies, Inc. | 2003-02-14 |
Legacy Summary#
summary
FDA Review#
Decision Summary