Calbiochem-Behring Corp.
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 41
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K831811 | REVOLUTION RADIAL IMMUNODIFFUSION PLATE | July 28, 1983 |
| K831036 | ENA TEST KIT SM & RNP AUTO ANTIBODY | April 27, 1983 |
| K830214 | AFT SYSTEM III | March 9, 1983 |
| K820812 | CREATINE KINASE-MB KIT | April 12, 1982 |
| K813493 | ENZYGNOST TM RUBELLA IGM | March 4, 1982 |
| K820088 | AFT SYSTEM PROFICIENCY TESTING PROGRAM | January 26, 1982 |
| K812458 | PADAC | September 23, 1981 |
| K810718 | C-PEPTICE REAGENTS | March 31, 1981 |
| K810669 | PANTRAK E.K. | March 31, 1981 |
| K810309 | RUBELLA ANTIBODIES TEST REAGENTS | March 11, 1981 |
| K810404 | RHEUMATOID FACTORS REFERENCE SERUM | March 11, 1981 |
| K802102 | RUBELLA ELISA REAGENTS RUBELLA IGG ANTI | December 18, 1980 |
| K802153 | CBC PAP TEST KIT | November 12, 1980 |
| K801198 | FOLATE RADIOASSAY KIT | July 21, 1980 |
| K801105 | THYROXINE RADIOIMMUNOASSAY KIT | June 9, 1980 |
| K801123 | TRIIODOTHYRONINE RADIOIMMUN. SYSTEM | June 9, 1980 |
| K800995 | IMMUNOGLOBULIN E TEST KIT | May 14, 1980 |
| K800821 | AFT TM SYSTEM ANTIMITOCHONDRIAL ANTIBODY | April 24, 1980 |
| K800642 | RAPI/TEX ASO STANDARD SERUM | April 24, 1980 |
| K800820 | AFT TM SYSTEM ANTISMOOTH MUSCLE ANTIBODY | April 24, 1980 |