FDA product code JLC: Nitroprusside Reaction (Qualitative, Urine), Cystine
JLC is the FDA product code for nitroprusside reaction (qualitative, urine), cystine. It is a Class I device, regulated under 21 CFR 862.1240 and reviewed by the Clinical Chemistry panel. FDA has cleared 2 510(k) submissions under JLC, from 2 different applicants. The average 510(k) review took 70 days (median 70).
Classification
| Field | Value |
|---|---|
| Device name | Nitroprusside Reaction (Qualitative, Urine), Cystine |
| Device class | Class I |
| Regulation | 21 CFR 862.1240 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Top JLC applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Mission Pharmacal Co. | 1 | 1985-01-08 |
| Sandare Chemical Co., Inc. | 1 | 1981-03-04 |
Most recent JLC clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K843382 | Mission Pharmacal Co. | UROCYSTIN | 1985-01-08 | 133 |
| K810514 | Sandare Chemical Co., Inc. | SANDARE NITROPRUSSIDE TEST PROCEDURE | 1981-03-04 | 7 |
Recalls for JLC devices
openFDA lists no recalls for product code JLC.
Frequently asked questions
What is FDA product code JLC?
JLC is the FDA product code for nitroprusside reaction (qualitative, urine), cystine. It is a Class I device, regulated under 21 CFR 862.1240 and reviewed by the Clinical Chemistry panel.
What device class is JLC?
Class I, regulation 21 CFR 862.1240. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code JLC?
Across 2 cleared submissions the average was 70 days from receipt to decision (median 70).
Which companies have the most JLC clearances?
Mission Pharmacal Co. (1); Sandare Chemical Co., Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code JLC
- Run a recall and safety report across every JLC manufacturer
- Watch product code JLC 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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