Horizon Diagnostics, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 7
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K971566 | CREATINE KINASE-MB REAGENT SET | July 14, 1997 |
| K933722 | HORIZON DIAGNOSTICS TRIGLYCERIDES-GPO REAGENT | June 13, 1996 |
| K935712 | IRON/TIBC REAGENT | September 20, 1995 |
| K930678 | AMYLASE | April 6, 1994 |
| K934533 | BUN-300/BUN-500 UREA NITROGEN REAGENT | November 26, 1993 |
| K930679 | DIRECT BILIRUBIN | June 29, 1993 |
| K930074 | IN-VITRO DIAGNOSTIC REAGENT SET | May 11, 1993 |