JQX
14 FDA 510(k) clearances · Product code
34 daysmedian time to decision
95 days90th percentile
14clearances measured
FDA profile
- Official device name
- Nephelometer, For Clinical Use
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.2700
- Medical specialty
- Clinical Chemistry
- Adverse events (MAUDE)
- 2012: 16 · 2022: 24 · 2023: 27 · 2024: 78 · 2025: 18 · 2026: 14
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| IMMAGE IMMUNOCHEMISTRY SYSTEM (K962294) | Beckman Instruments, Inc. | 1996-08-21 |
| ARRAY(R) 360 (K922273) | Beckman Instruments, Inc. | 1992-08-19 |
| QMS(TM) - THEOPHYLLINE (K885263) | Seradyn, Inc. | 1989-03-28 |
| TDX ANALYZER W/NEPHELOMETRY CAROUSEL (K851253) | Abbott Laboratories | 1985-04-30 |
| A-JUST TURBIDITY METER (K851234) | Abbott Laboratories | 1985-04-29 |
| ALBUMIN NEPHELOMETRIC ASSAY (K801362) | J.T. Baker Chemical Co. | 1980-07-21 |
| J.T. BAKER NEPHELOMETER (K801089) | J.T. Baker Chemical Co. | 1980-05-28 |
| BIOVATION NEPHELOMETER (K792045) | Biovation, Inc. | 1979-10-30 |
| NEPHELOMETER, MIC-2000 LASER (K790103) | Dynatech Corp. | 1979-03-12 |
| RAD-291 (K781554) | Organon, Inc. | 1978-10-11 |
| ANTIBIOTIC NEPHELOMETER (K781644) | Biovation, Inc. | 1978-10-03 |
| NEPHELOMETER (K780251) | Kallestad Laboratories, Inc. | 1978-04-06 |
| LASER IMMUNONEPHELOMETRIC ANALYZER (K772361) | G.D. Searle and Co. | 1978-01-30 |
| TRANSPORTEO MODULE (K771446) | Hyland Therapeutic Div., Travenol Laboratories | 1977-08-10 |
Track JQX automatically
Every clearance here is in the API, with alerts when new ones post.