FDA product code JJE: Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
JJE is the FDA product code for analyzer, chemistry (photometric, discrete), for clinical use. It is a Class I device, regulated under 21 CFR 862.2160 and reviewed by the Clinical Chemistry panel. FDA has cleared 208 510(k) submissions under JJE, from 99 different applicants. The average 510(k) review took 71 days (median 54). 1 PMA application cites this product code. FDA has posted 561 recalls for JJE devices, 89 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use |
| Device class | Class I |
| Regulation | 21 CFR 862.2160 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
510(k) clearances per year for JJE
| Year | Clearances | Avg. review days |
|---|---|---|
| 2019 | 1 | 68 |
Compare with all 510(k) review times · Search every JJE clearance
Top JJE applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Eastman Kodak Company | 18 | 1992-07-10 |
| Boehringer Mannheim Corp. | 16 | 1996-06-14 |
| Abbott Laboratories | 13 | 1998-02-13 |
| Beckman Instruments, Inc. | 9 | 1997-03-10 |
| E.I. Dupont DE Nemours & Co., Inc. | 7 | 1994-11-10 |
94 more applicants have JJE clearances. See the full list in Caduvo.
Most recent JJE clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K183375 | Horiba, Ltd. | Yumizen C1200, Yumizen C1200 Glucose HK, Sodium Electrode, Potassium Electrode, Chloride Electrode | 2019-02-12 | 68 |
| K133519 | Carolina Liquid Chemistries Corp. | CAROLINA LIQUID CHEMISTRIES CLC 6410 CHEMISTRY ANALYZER; CAROLINA LIQUID CHEMISTRIES GLUCOSE REAGENT, CAR | 2014-05-16 | 182 |
| K130915 | Jas Diagnostics, Inc. | XL-200 CLINICAL CHEMISTRY ANALYZER, JAS GLUCOSE REAGENT, ISE REAGENT PACK | 2014-05-15 | 408 |
| K131554 | Randox Laboratories, Ltd. | RX DAYTONA PLUS CHEMISTRY ANALYZER; RX DAYTONA PLUS ASPARTATE AMINOTRANSFERASE (AST) REAGENT | 2014-01-09 | 224 |
| K130276 | Siemens Healthcare Diagnostics, Inc. | DIMENSION EXL WITH LM SYSTEM | 2013-03-22 | 45 |
Recalls for JJE devices
561 product recalls in 332 recall events; 89 initiated in the last five years and 104 still open. Most recent: 2026-07-15.
| Year | Recalls |
|---|---|
| 2017 | 29 |
| 2018 | 34 |
| 2019 | 45 |
| 2020 | 26 |
| 2021 | 9 |
| 2022 | 4 |
| 2023 | 20 |
| 2024 | 33 |
| 2025 | 27 |
| 2026 | 3 |
Frequently asked questions
What is FDA product code JJE?
JJE is the FDA product code for analyzer, chemistry (photometric, discrete), for clinical use. It is a Class I device, regulated under 21 CFR 862.2160 and reviewed by the Clinical Chemistry panel.
What device class is JJE?
Class I, regulation 21 CFR 862.2160. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code JJE?
Across 208 cleared submissions the average was 71 days from receipt to decision (median 54).
Which companies have the most JJE clearances?
Eastman Kodak Company (18); Boehringer Mannheim Corp. (16); Abbott Laboratories (13); Beckman Instruments, Inc. (9); E.I. Dupont DE Nemours & Co., Inc. (7).
Have JJE devices been recalled?
Yes: 561 product recalls across 332 recall events; the most recent began 2026-07-15.
Next steps
- Run an FDA pathway report with predicate devices for product code JJE
- Run a recall and safety report across every JJE manufacturer
- Watch product code JJE 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.
All Clinical Chemistry product codes · FDA product code lookup · 510(k) database search · 510(k) review times