JHN
7 FDA 510(k) clearances · Product code
227 daysmedian time to decision
370 days90th percentile
7clearances measured
FDA profile
- Official device name
- Turbidimetric Method, Lipoproteins
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1475
- Medical specialty
- Clinical Chemistry
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| APOLIPOPROTEIN A-I IMMUNOTURBIDIMETRIC KIT (K950383) | Randox Laboratories, Ltd. | 1995-09-15 |
| APOLIPOPROTEIN B IMMUNOTURBIDIEMETRIC KIT (K950382) | Randox Laboratories, Ltd. | 1995-09-15 |
| WAKO AUTOKIT APO A1 (K952615) | Wako Chemicals USA, Inc. | 1995-09-08 |
| OLYMPUS APOLIPOPROTEIN A1 IMMUNOTURBIDIMETRIC REAGENT (K952425) | Olympus America, Inc. | 1995-07-05 |
| OLYMPUS APOLIPOPROTEIN B IMMUNOTURBIDIMETRIC REAGENT (K952466) | Olympus America, Inc. | 1995-06-05 |
| APOLIPOPROTIEN B (APO B) (K932603) | Sigma Diagnostics, Inc. | 1994-06-02 |
| APOLIPOPROTIEN A-1 (APO A-1) (K932606) | Sigma Diagnostics, Inc. | 1994-06-02 |
Track JHN automatically
Every clearance here is in the API, with alerts when new ones post.