FDA Product Code
FDA Product Code JHN — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1475
510(k) Clearances — 7 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K950383 | APOLIPOPROTEIN A-I IMMUNOTURBIDIMETRIC KIT | Randox Laboratories, Ltd. | 1995-09-15 | Traditional | PDF ↗ |
| K950382 | APOLIPOPROTEIN B IMMUNOTURBIDIEMETRIC KIT | Randox Laboratories, Ltd. | 1995-09-15 | Traditional | PDF ↗ |
| K952615 | WAKO AUTOKIT APO A1 | Wako Chemicals USA, Inc. | 1995-09-08 | Traditional | PDF ↗ |
| K952425 | OLYMPUS APOLIPOPROTEIN A1 IMMUNOTURBIDIMETRIC REAGENT | Olympus America, Inc. | 1995-07-05 | Traditional | PDF ↗ |
| K952466 | OLYMPUS APOLIPOPROTEIN B IMMUNOTURBIDIMETRIC REAGENT | Olympus America, Inc. | 1995-06-05 | Traditional | PDF ↗ |
| K932603 | APOLIPOPROTIEN B (APO B) | Sigma Diagnostics, Inc. | 1994-06-02 | Traditional | PDF ↗ |
| K932606 | APOLIPOPROTIEN A-1 (APO A-1) | Sigma Diagnostics, Inc. | 1994-06-02 | Traditional | PDF ↗ |
Product code JHN · Class I · Clinical Chemistry. Data: openFDA.