ISCHEMIA ALBUMIN COBALT BINDING TEST (ACB TEST) ASSAY— 510(k) K071587
Substantially EquivalentInverness Medical Innovations, Inc.
FDA 510(k) clearance K071587 for ISCHEMIA ALBUMIN COBALT BINDING TEST (ACB TEST) ASSAY, Substantially Equivalent on 2007-07-30. Applicant: Inverness Medical Innovations, Inc.. Device class: 1.
Clearance details
- Applicant
- Inverness Medical Innovations, Inc.
- Product code
- Code JJX
- Device class
- Class 1
- Regulation
- 21 CFR 862.1660
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Waltham, MA, US
Recent devices under product code JJX
view allMore clearances from Inverness Medical Innovations, Inc.
view all- K071265 — SMARTCHECK INR SYSTEM
- K060133 — ISCHEMIA ALBUMIN COBALT BINDING TEST (ACB) ASSAY VERIFICATION SET
- K053196 — ISCHEMIA ALBUMIN COBALT BINDING TEST (ACB TEST)
- K011479 — ONE TOUCH FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM, ONE TOUCH ULTRA BLOOD GLUCOSE MONITORING SYSTEM
- K011616 — INDUO BLOOD GLUCOSE METER
Adverse events under product code JJX
product code JJX- Other
- 2
- Total
- 2
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.