JHN — Turbidimetric Method, Lipoproteins Class I
FDA product code JHN covers "Turbidimetric Method, Lipoproteins", a Class I medical device regulated under 21 CFR 862.1475. Submissions are reviewed by the Clinical Chemistry panel. At least 7 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- JHN
- Device Class
- Class I
- Regulation Number
- 862.1475
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Clinical Chemistry
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K950382 | randox laboratories | APOLIPOPROTEIN B IMMUNOTURBIDIEMETRIC KIT | September 15, 1995 |
| K950383 | randox laboratories | APOLIPOPROTEIN A-I IMMUNOTURBIDIMETRIC KIT | September 15, 1995 |
| K952615 | wako chemicals usa | WAKO AUTOKIT APO A1 | September 8, 1995 |
| K952425 | olympus america | OLYMPUS APOLIPOPROTEIN A1 IMMUNOTURBIDIMETRIC REAGENT | July 5, 1995 |
| K952466 | olympus america | OLYMPUS APOLIPOPROTEIN B IMMUNOTURBIDIMETRIC REAGENT | June 5, 1995 |
| K932606 | sigma diagnostics | APOLIPOPROTIEN A-1 (APO A-1) | June 2, 1994 |
| K932603 | sigma diagnostics | APOLIPOPROTIEN B (APO B) | June 2, 1994 |