FDA product code LFQ: Acid, Uric, Acid Reduction Of Ferric Ion
LFQ is the FDA product code for acid, uric, acid reduction of ferric ion. It is a Class I device, regulated under 21 CFR 862.1775 and reviewed by the Clinical Chemistry panel. FDA has cleared 5 510(k) submissions under LFQ, from 5 different applicants. The average 510(k) review took 30 days (median 28). FDA has posted 1 recall for LFQ devices.
Classification
| Field | Value |
|---|---|
| Device name | Acid, Uric, Acid Reduction Of Ferric Ion |
| Device class | Class I |
| Regulation | 21 CFR 862.1775 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every LFQ clearance
Top LFQ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Technostics Intl. | 1 | 1986-02-19 |
| Sterling Diagnostics, Inc. | 1 | 1986-02-11 |
| Livonia Diagnostics, Inc. | 1 | 1984-10-30 |
| Sandare Chemical Co., Inc. | 1 | 1981-09-01 |
| Anco Medical Reagents & Assoc. | 1 | 1981-08-20 |
Most recent LFQ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K860111 | Technostics Intl. | URIC ACID REAGENT SET | 1986-02-19 | 37 |
| K860142 | Sterling Diagnostics, Inc. | URIC ACID REAGENT SET (COLORIMETRIC) | 1986-02-11 | 28 |
| K844075 | Livonia Diagnostics, Inc. | URIC ACID REAGENT SET | 1984-10-30 | 11 |
| K812313 | Sandare Chemical Co., Inc. | SANDARE URIC ACID PROCEDURE | 1981-09-01 | 15 |
| K811764 | Anco Medical Reagents & Assoc. | URIC ACID REAGENT SET | 1981-08-20 | 59 |
Recalls for LFQ devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2016-07-20.
Frequently asked questions
What is FDA product code LFQ?
LFQ is the FDA product code for acid, uric, acid reduction of ferric ion. It is a Class I device, regulated under 21 CFR 862.1775 and reviewed by the Clinical Chemistry panel.
What device class is LFQ?
Class I, regulation 21 CFR 862.1775. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code LFQ?
Across 5 cleared submissions the average was 30 days from receipt to decision (median 28).
Which companies have the most LFQ clearances?
Technostics Intl. (1); Sterling Diagnostics, Inc. (1); Livonia Diagnostics, Inc. (1); Sandare Chemical Co., Inc. (1); Anco Medical Reagents & Assoc. (1).
Have LFQ devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2016-07-20.
Next steps
- Run an FDA pathway report with predicate devices for product code LFQ
- Run a recall and safety report across every LFQ manufacturer
- Watch product code LFQ 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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