ALBUMIN COBALT BINDING TEST (ACB TEST)
FDA 510(k) clearance K023824 · decided 2003-02-14
Clearance details
- K-number
- K023824
- Device name
- ALBUMIN COBALT BINDING TEST (ACB TEST)
- Applicant
- Ischemia Technologies, Inc.
- Decision
- Unknown
- Date received
- 2002-11-18
- Decision date
- 2003-02-14
- Days to decision
- 88 days
- Clearance type
- Traditional
- Product code
- NJV
- Device class
- 2
- Regulation number
- 862.1215
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Denver, CO, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Ischemia Technologies
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| ISCHEMIA ALBUMIN COBALT BINDING TEST (ACB TEST) (K053196) | Inverness Medical Innovations, Inc. | 2005-12-16 |
Recalls involving this device
No recalls on record reference this clearance.