Panels › Clinical Chemistry › Product code JHN · Class 1
Turbidimetric Method, Lipoproteins
Regulation 862.1475
0510(k)s in 12 months (7 all time)
0recalls in 12 months (1 all time)
1recalls that name a 510(k)
Top companies in JHN
| Company | 510(k)s | Recalls |
|---|---|---|
| Olympus America, Inc. | 2 | 0 |
| Randox Laboratories, Ltd. | 2 | 0 |
| Sigma Diagnostics, Inc. | 2 | 0 |
| Beckman Coulter Ireland, Inc. | 0 | 1 |
| Wako Chemicals USA, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 15, 1995 | K950383 | APOLIPOPROTEIN A-I IMMUNOTURBIDIMETRIC KIT Randox Laboratories, Ltd., IE | JHN |
| Sep 15, 1995 | K950382 | APOLIPOPROTEIN B IMMUNOTURBIDIEMETRIC KIT Randox Laboratories, Ltd., IE | JHN |
| Sep 8, 1995 | K952615 | WAKO AUTOKIT APO A1 Wako Chemicals USA, Inc. | JHN |
| Jul 5, 1995 | K952425 | OLYMPUS APOLIPOPROTEIN A1 IMMUNOTURBIDIMETRIC REAGENT Olympus America, Inc. | JHN |
| Jun 5, 1995 | K952466 | OLYMPUS APOLIPOPROTEIN B IMMUNOTURBIDIMETRIC REAGENT Olympus America, Inc. | JHN |
| Jun 2, 1994 | K932606 | APOLIPOPROTIEN A-1 (APO A-1) Sigma Diagnostics, Inc. | JHN |
| Jun 2, 1994 | K932603 | APOLIPOPROTIEN B (APO B) Sigma Diagnostics, Inc. | JHN |
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