ISCHEMIA ALBUMIN COBALT BINDING TEST (ACB TEST)
FDA 510(k) clearance K053196 · decided 2005-12-16
Clearance details
- K-number
- K053196
- Device name
- ISCHEMIA ALBUMIN COBALT BINDING TEST (ACB TEST)
- Applicant
- Inverness Medical Innovations, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2005-11-16
- Decision date
- 2005-12-16
- Days to decision
- 30 days
- Clearance type
- Special
- Product code
- NJV
- Device class
- 2
- Regulation number
- 862.1215
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Waltham, MA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| ALBUMIN COBALT BINDING TEST (ACB TEST) (K023824) | Ischemia Technologies, Inc. | 2003-02-14 |
Recalls involving this device
No recalls on record reference this clearance.