Panels › Clinical Chemistry
Clinical Chemistry devices
409 product codes reviewed by the Clinical Chemistry panel. 13,074 510(k) clearances and 3,481 recalls in the FDA data, 72% of those recalls name a 510(k).
71510(k)s in 12 months
180recalls in 12 months
2,491recalls that name a 510(k)
Active product codes, Class I
| Code | Device | Class | 510(k)s, 12 mo | Recalls, 12 mo |
|---|---|---|---|---|
| JJE | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | 1 | 0 | 10 |
| OHQ | Multi-Analyte Controls Unassayed | 1 | 0 | 5 |
| CEN | Dye-Indicator, Ph (Urinary, Non-Quantitative) | 1 | 0 | 4 |
| JIR | Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) | 1 | 0 | 4 |
| CDZ | Radioimmunoassay, Testosterones And Dihydrotestosterone | 1 | 1 | 2 |
| NRH | System, Breath Measurement | 1 | 0 | 3 |
| CHH | Enzymatic Esterase--Oxidase, Cholesterol | 1 | 1 | 1 |
| JIN | Nitroprusside, Ketones (Urinary, Non-Quant.) | 1 | 0 | 2 |
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | 0 | 2 |
| JKC | Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate) | 1 | 0 | 2 |
| JQC | Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use | 1 | 0 | 2 |
| JQP | Calculator/Data Processing Module, For Clinical Use | 1 | 0 | 2 |
| KQO | Automated Urinalysis System | 1 | 0 | 2 |
| NGA | Test, Follicle Stimulating Hormone (Fsh), Over The Counter | 1 | 0 | 2 |
| NGE | Test, Luteinizing Hormone (Lh), Over The Counter | 1 | 0 | 2 |
| PHV | Continuous Glucose Monitor Retrospective Data Analysis Software | 1 | 0 | 2 |
| QBV | Centrifuge For Preparation Of Cell Concentrate And/Or Plasma Concentrate | 1 | 2 | 0 |
| CDA | Acid, Nitrous And Nitrosonaphthol, 5-Hydroxyindole Acetic Acid/Serotonin | 1 | 0 | 1 |
| CGF | Radioimmunoassay, Estrone | 1 | 0 | 1 |
| CHM | Radioimmunoassay, Total Estrogens In Pregnancy | 1 | 0 | 1 |
| JID | Photometric Method, Ammonia | 1 | 1 | 0 |
| JIJ | Wet Ash Method, Protein-Bound Iodine | 1 | 0 | 1 |
| JIY | Photometric Method, Iron (Non-Heme) | 1 | 0 | 1 |
| JJH | Clinical Sample Concentrator | 1 | 0 | 1 |
| JJW | Urinalysis Controls (Assayed And Unassayed) | 1 | 0 | 1 |
| JMT | Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) | 1 | 1 | 0 |
| KNK | Acid, Uric, Uricase (Colorimetric) | 1 | 0 | 1 |
| LBS | Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl | 1 | 0 | 1 |
| LNW | Paper, Obstetric Ph | 1 | 0 | 1 |
| LXG | Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use | 1 | 0 | 1 |
| NAQ | Lipoprotein, High Density, Hdl, Over The Counter | 1 | 0 | 1 |
| PER | Automated Pipetting, Diluting And Specimen Processing Workstations For Flow Cytometric Analysis | 1 | 0 | 1 |
| PFT | Reagents For Molecular Diagnostic Test Systems | 1 | 0 | 1 |
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