Calbiochem-Behring Corp.
Medical device manufacturer in Mchenry, IL.
41510(k) clearances
0PMA approvals
0recalls
Device types
- GOL Antigen, Ha (Including Ha Control), Rubella 2
- DHR System, Test, Rheumatoid Factor 2
- DHN Antinuclear Antibody, Indirect… 2
- CDT Lipase Hydrolysis/Glycerol Kinase Enzyme… 1
- JZQ Plates And Equipment, Radial Immunodiffusion 1
- CDD Radioassay, Vitamin B12 1
- DFT Igm, Antigen, Antiserum, Control 1
- DEW Igg, Antigen, Antiserum, Control 1
- GHH Fibrin Split Products 1
- LGO Test, Leukocyte Typing 1
- KTQ Reagent, Complement 1
- GTR Antideoxyribonuclease, Streptococcus Spp. 1
- JLS Radioimmunoassay, Progesterone 1
- CFL Radioimmunoassay, Human Growth Hormone 1
- GMM Antigens, Iha, Toxoplasma Gondii 1
- CHH Enzymatic Esterase--Oxidase, Cholesterol 1
- JJY Multi-Analyte Controls, All Kinds (Assayed) 1
- CDO Acid, Uric, Uricase (U.V.) 1
- JMG Radioimmunoassay (Two-Site Solid Phase)… 1
- CGJ Radioimmunoassay, Follicle-Stimulating… 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K831811 | Revolution Radial Immunodiffusion PlateJZQ · Traditional | 07/28/1983SE |
| K831036 | Ena Test Kit SM & RNP Auto AntibodyLLL · Traditional | 04/27/1983SE |
| K830214 | Aft System IIIDHN · Traditional | 03/09/1983SE |
| K820812 | Creatine Kinase-Mb KitJHY · Traditional | 04/12/1982SE |
| K813493 | Enzygnost TM Rubella IgmLFX · Traditional | 03/04/1982SE |
| K820088 | Aft System Proficiency Testing ProgramDBL · Traditional | 01/26/1982SE |
| K812458 | PadacJTO · Traditional | 09/23/1981SE |
| K810718 | C-Peptice ReagentsJKD · Traditional | 03/31/1981SE |
| K810669 | Pantrak E.K.CIW · Traditional | 03/31/1981SE |
| K810404 | Rheumatoid Factors Reference SerumDHR · Traditional | 03/11/1981SE |
| K810309 | Rubella Antibodies Test ReagentsGOL · Traditional | 03/11/1981SE |
| K802102 | Rubella Elisa Reagents Rubella Igg AntiGOL · Traditional | 12/18/1980SE |
| K802153 | CBC Pap Test KitJFH · Traditional | 11/12/1980SE |
| K801198 | Folate Radioassay KitCGN · Traditional | 07/21/1980SE |
| K801123 | Triiodothyronine Radioimmun. SystemCDP · Traditional | 06/09/1980SE |
| K801105 | Thyroxine Radioimmunoassay KitCDX · Traditional | 06/09/1980SE |
| K800995 | Immunoglobulin E Test KitDGO · Traditional | 05/14/1980SE |
| K800821 | Aft TM System Antimitochondrial AntibodyDBM · Traditional | 04/24/1980SE |
| K800820 | Aft TM System Antismooth Muscle AntibodyDBE · Traditional | 04/24/1980SE |
| K800642 | Rapi/Tex Aso Standard SerumGTQ · Traditional | 04/24/1980SE |
| K800212 | Complement C3 Reagent SystemCZW · Traditional | 02/19/1980SE |
| K800211 | Immunoglobulin a Reagent SystemCZP · Traditional | 02/19/1980SE |
| K792460 | Calbiochem-Behring Ria-CountCDD · Traditional | 02/13/1980SE |
| K800167 | Immunoglobulin M Reagent SystemDFT · Traditional | 02/05/1980SE |
| K800119 | Immunoglobulin G Reagent SystemDEW · Traditional | 02/05/1980SE |
| K791358 | Fibro-Tec Test KitGHH · Traditional | 09/04/1979SE |
| K791118 | Hla Control SeraLGO · Traditional | 08/03/1979SE |
| K791117 | Rabbit ComplementKTQ · Traditional | 08/03/1979SE |
| K790997 | Anti-Dnase B Reagent SystemGTR · Traditional | 07/24/1979SE |
| K790911 | Ria of ProgesteroneJLS · Traditional | 06/27/1979SE |
| K790773 | Enzymatic Triglycerides-S.V.R.CDT · Traditional | 06/15/1979SE |
| K790460 | Txocell-Iha Reagent SystemGMM · Traditional | 05/25/1979SE |
| K790556 | Cholesterol Reagent, Automated EnzymaticCHH · Traditional | 05/07/1979SE |
| K790280 | Autoantibody Reagents, Aft System IIDHN · Traditional | 04/23/1979SE |
| K790330 | Calbiochem-Behring Laser ImmunoglobulinJJY · Traditional | 03/15/1979SE |
| K790012 | Rheumogen Test SystemDHR · Traditional | 01/26/1979SE |
| K781996 | Acid Reagent, Uric Single VialCDO · Traditional | 01/03/1979SE |
| K781527 | Ria System for Human Fe-RitinJMG · Traditional | 10/03/1978SE |
| K780870 | Ria System for Human F-S HormoneCGJ · Traditional | 06/22/1978SE |
| K780367 | Ria Sys. for Human Luteinizing HormoneCEP · Traditional | 04/28/1978SE |
| K780347 | Ria Sys. for Human Growth HormoneCFL · Traditional | 04/12/1978SE |