Bathophenanthroline, Iron Binding Capacity
The Bathophenanthroline, Iron Binding Capacity test is a clinical chemistry diagnostic reagent that uses bathophenanthroline as a chromogenic chelating agent to colorimetrically measure iron binding capacity in serum, supporting the diagnosis and monitoring of iron deficiency anemia, hemochromatosis, and other disorders of iron metabolism. This device is FDA Class 1, the lowest risk category, requiring only general controls and no premarket notification. It carries product code JQF and is regulated under 21 CFR 862.1415, within the Clinical Chemistry medical specialty.
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Basic Information
- Product Code
- JQF
- Device Class
- FDA class 1
- Regulation Number
- 862.1415
- Medical Specialty
- Clinical Chemistry
- Review Panel
- CH
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 8 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K051111 | SENTINEL UIBC LIQUID | Nov 17, 2005 | Substantially Equivalent | Sentinel Ch. Srl |
| K984122 | WAKO L-TYPE UIBC, WAKO UIBC CALIBRATOR | Jan 20, 1999 | Substantially Equivalent | Wako Chemicals USA, Inc. |
| K875176 | WAKO(TM) UIBC | Feb 02, 1988 | Substantially Equivalent | Wako Chemicals USA, Inc. |
| K863066 | TRANSFERMETER | Dec 04, 1986 | Substantially Equivalent | J. D. Assoc. |
| K830032 | TOTAL IRON BINDING CAPACITY TEST | Jan 28, 1983 | Substantially Equivalent | Sclavo, Inc. |
| K811942 | J & S IRON SATURATING REAGENT | Sep 08, 1981 | Substantially Equivalent | Thyroid Diagnostics, Inc. |
| K810086 | IRON & TICB | Jan 28, 1981 | Substantially Equivalent | Bio-Analytics Laboratories, Inc. |
| K792409 | ELVI TOTAL IRON BINDING CAPACITY | Dec 06, 1979 | Substantially Equivalent | Volu Sol Medical Industries |
FEI Numbers
This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.