Ischemia Albumin Cobalt Binding Test (Acb Test) Assay
FDA 510(k) K071587 · Inverness Medical Innovations, Inc.
510(k) numberK071587
Submission
- Device name
- Ischemia Albumin Cobalt Binding Test (Acb Test) Assay
- Applicant
- Inverness Medical Innovations, Inc.
Waltham, MA, US - Received
- June 11, 2007
- Decision date
- July 30, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JJX – Single (Specified) Analyte Controls (Assayed And Unassayed)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1660
- Specialty
- Clinical Chemistry
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Questions and answers
When was Ischemia Albumin Cobalt Binding Test (Acb Test) Assay cleared by the FDA?
Ischemia Albumin Cobalt Binding Test (Acb Test) Assay (K071587) received a 510(k) decision of Substantially Equivalent on July 30, 2007, 49 days after the submission was received.
What is the product code of K071587?
The FDA product code is JJX – Single (Specified) Analyte Controls (Assayed And Unassayed), a Class I (low risk) device regulated under 21 CFR 862.1660.