Biodiagnostic Intl
Medical device manufacturer in Brea, CA.
11510(k) clearances
0PMA approvals
0recalls
Device types
- JJY Multi-Analyte Controls, All Kinds (Assayed) 3
- DIF Drug Mixture Control Materials 2
- DKB Calibrators, Drug Mixture 1
- JJW Urinalysis Controls (Assayed And Unassayed) 1
- KRZ Calibrator For Hemoglobin And Hematocrit… 1
- JIT Calibrator, Secondary 1
- JJX Single (Specified) Analyte Controls… 1
- LCP Assay, Glycosylated Hemoglobin 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K031296 | Liqui-Heme Glyco A1C AssayLCP · Traditional | 10/15/2004SE |
| K881430 | Liqui-Sera Serum Alcohol ControlsJJX · Traditional | 07/08/1988SE |
| K874459 | Liqui-Sera Spinal Fluid ControlJJY · Traditional | 12/29/1987SE |
| K863849 | Liqui-Sera Combo Ligand/Tdm ControlsJJY · Traditional | 11/24/1986SE |
| K853906 | Liqui-Sera Chemistry Controls (Comprehensive)JJY · Traditional | 10/04/1985SE |
| K853887 | Liqui-Sera Chem. Multiple CalibratorsJIT · Traditional | 09/30/1985SE |
| K842668 | Liqui-Heme Hemoglobin CalibratorsKRZ · Traditional | 03/05/1985SE |
| K840618 | Liqui-Ura Chemistry Urine ControlsJJW · Traditional | 04/04/1984SE |
| K834398 | Liqui-Sera TDM CalibratorsDKB · Traditional | 02/03/1984SE |
| K834259 | Liqui-Ura Toxic Urine ControlDIF · Traditional | 01/30/1984SE |
| K831278 | Liqui-Sera Anticonvulsants ControlsDIF · Traditional | 05/27/1983SE |