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
- 510(k) Exempt
- 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 | Sep 15, 1995 |
| K950383 | Randox Laboratories | APOLIPOPROTEIN A-I IMMUNOTURBIDIMETRIC KIT | Sep 15, 1995 |
| K952615 | Wako Chemicals Usa | WAKO AUTOKIT APO A1 | Sep 8, 1995 |
| K952425 | Olympus America | OLYMPUS APOLIPOPROTEIN A1 IMMUNOTURBIDIMETRIC REAGENT | Jul 5, 1995 |
| K952466 | Olympus America | OLYMPUS APOLIPOPROTEIN B IMMUNOTURBIDIMETRIC REAGENT | Jun 5, 1995 |
| K932603 | Sigma Diagnostics | APOLIPOPROTIEN B (APO B) | Jun 2, 1994 |
| K932606 | Sigma Diagnostics | APOLIPOPROTIEN A-1 (APO A-1) | Jun 2, 1994 |