JQF · Bathophenanthroline, Iron Binding Capacity
Clinical Chemistry · 21 CFR 862.1415 · Class 1
Overview
| Product Code | JQF |
|---|---|
| Device Name | Bathophenanthroline, Iron Binding Capacity |
| Regulation | 21 CFR 862.1415 |
| Device Class | Class 1 |
| Review Panel | Clinical Chemistry |
Identification
An iron-binding capacity test system is a device intended to measure iron-binding capacity in serum. Iron-binding capacity measurements are used in the diagnosis and treatment of anemia.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
Recent Cleared Devices (8 of 8)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K051111 | SENTINEL UIBC LIQUID | Sentinel Ch. Srl | Nov 17, 2005 | SESE |
| K984122 | WAKO L-TYPE UIBC, WAKO UIBC CALIBRATOR | Wako Chemicals USA, Inc. | Jan 20, 1999 | SESE |
| K875176 | WAKO(TM) UIBC | Wako Chemicals USA, Inc. | Feb 2, 1988 | SESE |
| K863066 | TRANSFERMETER | J. D. Assoc. | Dec 4, 1986 | SESE |
| K830032 | TOTAL IRON BINDING CAPACITY TEST | Sclavo, Inc. | Jan 28, 1983 | SESE |
| K811942 | J & S IRON SATURATING REAGENT | Thyroid Diagnostics, Inc. | Sep 8, 1981 | SESE |
| K810086 | IRON & TICB | Bio-Analytics Laboratories, Inc. | Jan 28, 1981 | SESE |
| K792409 | ELVI TOTAL IRON BINDING CAPACITY | Volu Sol Medical Industries | Dec 6, 1979 | SESE |
Top Applicants
- Wako Chemicals USA, Inc. — 2 clearances
- Bio-Analytics Laboratories, Inc. — 1 clearance
- J. D. Assoc. — 1 clearance
- Sclavo, Inc. — 1 clearance
- Sentinel Ch. Srl — 1 clearance
