FDA product code JQF: Bathophenanthroline, Iron Binding Capacity
JQF is the FDA product code for bathophenanthroline, iron binding capacity. It is a Class I device, regulated under 21 CFR 862.1415 and reviewed by the Clinical Chemistry panel. FDA has cleared 8 510(k) submissions under JQF, from 7 different applicants. The average 510(k) review took 66 days (median 55).
Classification
| Field | Value |
|---|---|
| Device name | Bathophenanthroline, Iron Binding Capacity |
| Device class | Class I |
| Regulation | 21 CFR 862.1415 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every JQF clearance
Top JQF applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Wako Chemicals USA, Inc. | 2 | 1999-01-20 |
| Sentinel Ch. Srl | 1 | 2005-11-17 |
| J. D. Assoc. | 1 | 1986-12-04 |
| Sclavo, Inc. | 1 | 1983-01-28 |
| Thyroid Diagnostics, Inc. | 1 | 1981-09-08 |
2 more applicants have JQF clearances. See the full list in Caduvo.
Most recent JQF clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K051111 | Sentinel Ch. Srl | SENTINEL UIBC LIQUID | 2005-11-17 | 199 |
| K984122 | Wako Chemicals USA, Inc. | WAKO L-TYPE UIBC, WAKO UIBC CALIBRATOR | 1999-01-20 | 63 |
| K875176 | Wako Chemicals USA, Inc. | WAKO(TM) UIBC | 1988-02-02 | 47 |
| K863066 | J. D. Assoc. | TRANSFERMETER | 1986-12-04 | 114 |
| K830032 | Sclavo, Inc. | TOTAL IRON BINDING CAPACITY TEST | 1983-01-28 | 21 |
Recalls for JQF devices
openFDA lists no recalls for product code JQF.
Frequently asked questions
What is FDA product code JQF?
JQF is the FDA product code for bathophenanthroline, iron binding capacity. It is a Class I device, regulated under 21 CFR 862.1415 and reviewed by the Clinical Chemistry panel.
What device class is JQF?
Class I, regulation 21 CFR 862.1415. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code JQF?
Across 8 cleared submissions the average was 66 days from receipt to decision (median 55).
Which companies have the most JQF clearances?
Wako Chemicals USA, Inc. (2); Sentinel Ch. Srl (1); J. D. Assoc. (1); Sclavo, Inc. (1); Thyroid Diagnostics, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code JQF
- Run a recall and safety report across every JQF manufacturer
- Watch product code JQF for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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