FDA product code JIM: Method, Metallic Reduction, Glucose (Urinary, Non-Quantitative)
JIM is the FDA product code for method, metallic reduction, glucose (urinary, non-quantitative). It is a Class II device, regulated under 21 CFR 862.1340 and reviewed by the Clinical Chemistry panel. FDA has cleared 2 510(k) submissions under JIM, from 2 different applicants. The average 510(k) review took 42 days (median 42).
Classification
| Field | Value |
|---|---|
| Device name | Method, Metallic Reduction, Glucose (Urinary, Non-Quantitative) |
| Device class | Class II |
| Regulation | 21 CFR 862.1340 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every JIM clearance
Top JIM applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Hichem Diagnostics | 1 | 1990-06-12 |
| Boehringer Mannheim Corp. | 1 | 1979-06-15 |
Most recent JIM clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K902155 | Hichem Diagnostics | HI CHEM ISE REAGENTS (PRODUCTS #88960 AND #88964) | 1990-06-12 | 28 |
| K790772 | Boehringer Mannheim Corp. | CHEMTAB | 1979-06-15 | 56 |
Recalls for JIM devices
openFDA lists no recalls for product code JIM.
Frequently asked questions
What is FDA product code JIM?
JIM is the FDA product code for method, metallic reduction, glucose (urinary, non-quantitative). It is a Class II device, regulated under 21 CFR 862.1340 and reviewed by the Clinical Chemistry panel.
What device class is JIM?
Class II, regulation 21 CFR 862.1340. Typical premarket route: 510(k).
How long does a 510(k) take for product code JIM?
Across 2 cleared submissions the average was 42 days from receipt to decision (median 42).
Which companies have the most JIM clearances?
Hichem Diagnostics (1); Boehringer Mannheim Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code JIM
- Run a recall and safety report across every JIM manufacturer
- Watch product code JIM 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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