Total Iron Binding Capacity Test
FDA 510(k) K830032 · Sclavo, Inc.
510(k) numberK830032
Submission
- Device name
- Total Iron Binding Capacity Test
- Applicant
- Sclavo, Inc.
Mchenry, IL, US - Received
- January 7, 1983
- Decision date
- January 28, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JQF – Bathophenanthroline, Iron Binding Capacity
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1415
- Specialty
- Clinical Chemistry
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Questions and answers
When was Total Iron Binding Capacity Test cleared by the FDA?
Total Iron Binding Capacity Test (K830032) received a 510(k) decision of Substantially Equivalent on January 28, 1983, 21 days after the submission was received.
What is the product code of K830032?
The FDA product code is JQF – Bathophenanthroline, Iron Binding Capacity, a Class I (low risk) device regulated under 21 CFR 862.1415.