21 CFR Part 862 · 16,006 FDA 510(k) clearances
| Code | Example device | Devices |
|---|---|---|
| JJY | Multichem IA Plus | 673 |
| NBW | On Call® Sure GK Blood Glucose & Ketone Monitoring System; On Call® Sure Sync GK Blood Glucose & Ketone Monitoring System | 508 |
| JJX | Beta-CrossLaps CalCheck 5 | 493 |
| CGA | ABL90 FLEX PLUS System | 401 |
| JHI | Innovita HCG Pregnancy Rapid Combo Test | 375 |
| JIX | VITROS Chemistry Products Calibrator Kit 3 | 302 |
| JJQ | UBIT-IR300 INFRARED SPECTROMETRY SYSTEM | 258 |
| JIT | VITROS Immunodiagnostic Products Insulin Calibrators | 245 |
| JLW | Atellica® IM TSH3-Ultra II (TSH3ULII) | 242 |
| CIG | Atellica CH Diazo Total Bilirubin (D_TBil) | 235 |
| JKA | BD Preset and BD A-Line Arterial Blood Collection Syringes | 235 |
| CHH | Lipids | 230 |
| LCX | MissLan® Early Detection Digital Pregnancy Test; MissLan® Early Result Digital Pregnancy Test | 226 |
| DKZ | DRI Ecstasy Plus Assay | 225 |
| DJG | Labcorp Fentanyl Urine Visual Test | 215 |