FDA product code JJR: Electrolyte Controls (Assayed And Unassayed)
JJR is the FDA product code for electrolyte controls (assayed and unassayed). It is a Class I device, regulated under 21 CFR 862.1660 and reviewed by the Clinical Chemistry panel. FDA has cleared 17 510(k) submissions under JJR, from 14 different applicants. The average 510(k) review took 55 days (median 43).
Classification
| Field | Value |
|---|---|
| Device name | Electrolyte Controls (Assayed And Unassayed) |
| Device class | Class I |
| Regulation | 21 CFR 862.1660 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every JJR clearance
Top JJR applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Phoenix Diagnostics, Inc. | 2 | 1996-05-13 |
| Bionostics, Inc. | 2 | 1996-03-01 |
| Quantimetrix Corp. | 2 | 1994-10-04 |
| Medica Corp. | 1 | 1999-04-27 |
| Aalto Scientific, Ltd. | 1 | 1995-05-02 |
9 more applicants have JJR clearances. See the full list in Caduvo.
Most recent JJR clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K990971 | Medica Corp. | EASYLYTE QUALITY CONTROL KIT, MODELS 2814, 2815, 2816 | 1999-04-27 | 35 |
| K960592 | Phoenix Diagnostics, Inc. | ELECTROLYTE STANDARDS | 1996-05-13 | 91 |
| K955630 | Bionostics, Inc. | RNA MEDICAL HEMAT CONTROL | 1996-03-01 | 81 |
| K951435 | Aalto Scientific, Ltd. | AALTO SCIENTIFIC SWEAT CHLORIDE REFERENCE MATERIAL | 1995-05-02 | 36 |
| K943925 | Quantimetrix Corp. | SWEAT CONTROLS FOR CYSTIC FIBROSIS TESTING | 1994-10-04 | 53 |
Recalls for JJR devices
openFDA lists no recalls for product code JJR.
Frequently asked questions
What is FDA product code JJR?
JJR is the FDA product code for electrolyte controls (assayed and unassayed). It is a Class I device, regulated under 21 CFR 862.1660 and reviewed by the Clinical Chemistry panel.
What device class is JJR?
Class I, regulation 21 CFR 862.1660. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code JJR?
Across 17 cleared submissions the average was 55 days from receipt to decision (median 43).
Which companies have the most JJR clearances?
Phoenix Diagnostics, Inc. (2); Bionostics, Inc. (2); Quantimetrix Corp. (2); Medica Corp. (1); Aalto Scientific, Ltd. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code JJR
- Run a recall and safety report across every JJR manufacturer
- Watch product code JJR 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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