Company ยท US
Calbiochem-Behring Corp.
FDA 510(k) clearances and medical device recalls filed under this name, 1978 to 1983. Name variants (Inc, Corp, punctuation) are merged.
41510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| DHN | Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control | 2 |
| DHR | System, Test, Rheumatoid Factor | 2 |
| GOL | Antigen, Ha (Including Ha Control), Rubella | 2 |
| CDD | Radioassay, Vitamin B12 | 1 |
| CDO | Acid, Uric, Uricase (U.V.) | 1 |
| CDP | Radioimmunoassay, Total Triiodothyronine | 1 |
| CDT | Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides | 1 |
| CDX | Radioimmunoassay, Total Thyroxine | 1 |
| CEP | Radioimmunoassay, Luteinizing Hormone | 1 |
| CFL | Radioimmunoassay, Human Growth Hormone | 1 |
| CGJ | Radioimmunoassay, Follicle-Stimulating Hormone | 1 |
| CGN | Acid, Folic, Radioimmunoassay | 1 |
| CHH | Enzymatic Esterase--Oxidase, Cholesterol | 1 |
| CIW | Starch-Dye Bound Polymer, Amylase | 1 |
| CZP | Iga, Antigen, Antiserum, Control | 1 |
| CZW | Complement C3, Antigen, Antiserum, Control | 1 |
| DBE | Antismooth Muscle Antibody, Indirect Immunofluorescent, Antigen, Control | 1 |
| DBL | Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control | 1 |
| DBM | Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control | 1 |
| DEW | Igg, Antigen, Antiserum, Control | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 28, 1983 | K831811 | REVOLUTION RADIAL IMMUNODIFFUSION PLATE Calbiochem-Behring Corp. | JZQ |
| Apr 27, 1983 | K831036 | ENA TEST KIT SM & RNP AUTO ANTIBODY Calbiochem-Behring Corp. | LLL |
| Mar 9, 1983 | K830214 | AFT SYSTEM III Calbiochem-Behring Corp. | DHN |
| Apr 12, 1982 | K820812 | CREATINE KINASE-MB KIT Calbiochem-Behring Corp. | JHY |
| Mar 4, 1982 | K813493 | ENZYGNOST TM RUBELLA IGM Calbiochem-Behring Corp. | LFX |
| Jan 26, 1982 | K820088 | AFT SYSTEM PROFICIENCY TESTING PROGRAM Calbiochem-Behring Corp. | DBL |
| Sep 23, 1981 | K812458 | PADAC Calbiochem-Behring Corp. | JTO |
| Mar 31, 1981 | K810718 | C-PEPTICE REAGENTS Calbiochem-Behring Corp. | JKD |
| Mar 31, 1981 | K810669 | PANTRAK E.K. Calbiochem-Behring Corp. | CIW |
| Mar 11, 1981 | K810404 | RHEUMATOID FACTORS REFERENCE SERUM Calbiochem-Behring Corp. | DHR |
| Mar 11, 1981 | K810309 | RUBELLA ANTIBODIES TEST REAGENTS Calbiochem-Behring Corp. | GOL |
| Dec 18, 1980 | K802102 | RUBELLA ELISA REAGENTS RUBELLA IGG ANTI Calbiochem-Behring Corp. | GOL |
| Nov 12, 1980 | K802153 | CBC PAP TEST KIT Calbiochem-Behring Corp. | JFH |
| Jul 21, 1980 | K801198 | FOLATE RADIOASSAY KIT Calbiochem-Behring Corp. | CGN |
| Jun 9, 1980 | K801123 | TRIIODOTHYRONINE RADIOIMMUN. SYSTEM Calbiochem-Behring Corp. | CDP |
| Jun 9, 1980 | K801105 | THYROXINE RADIOIMMUNOASSAY KIT Calbiochem-Behring Corp. | CDX |
| May 14, 1980 | K800995 | IMMUNOGLOBULIN E TEST KIT Calbiochem-Behring Corp. | DGO |
| Apr 24, 1980 | K800821 | AFT TM SYSTEM ANTIMITOCHONDRIAL ANTIBODY Calbiochem-Behring Corp. | DBM |
| Apr 24, 1980 | K800820 | AFT TM SYSTEM ANTISMOOTH MUSCLE ANTIBODY Calbiochem-Behring Corp. | DBE |
| Apr 24, 1980 | K800642 | RAPI/TEX ASO STANDARD SERUM Calbiochem-Behring Corp. | GTQ |
| Feb 19, 1980 | K800212 | COMPLEMENT C3 REAGENT SYSTEM Calbiochem-Behring Corp. | CZW |
| Feb 19, 1980 | K800211 | IMMUNOGLOBULIN A REAGENT SYSTEM Calbiochem-Behring Corp. | CZP |
| Feb 13, 1980 | K792460 | CALBIOCHEM-BEHRING RIA-COUNT Calbiochem-Behring Corp. | CDD |
| Feb 5, 1980 | K800167 | IMMUNOGLOBULIN M REAGENT SYSTEM Calbiochem-Behring Corp. | DFT |
| Feb 5, 1980 | K800119 | IMMUNOGLOBULIN G REAGENT SYSTEM Calbiochem-Behring Corp. | DEW |
| Sep 4, 1979 | K791358 | FIBRO-TEC TEST KIT Calbiochem-Behring Corp. | GHH |
| Aug 3, 1979 | K791118 | HLA CONTROL SERA Calbiochem-Behring Corp. | LGO |
| Aug 3, 1979 | K791117 | RABBIT COMPLEMENT Calbiochem-Behring Corp. | KTQ |
| Jul 24, 1979 | K790997 | ANTI-DNASE B REAGENT SYSTEM Calbiochem-Behring Corp. | GTR |
| Jun 27, 1979 | K790911 | RIA OF PROGESTERONE Calbiochem-Behring Corp. | JLS |
| Jun 15, 1979 | K790773 | ENZYMATIC TRIGLYCERIDES-S.V.R. Calbiochem-Behring Corp. | CDT |
| May 25, 1979 | K790460 | TXOCELL-IHA REAGENT SYSTEM Calbiochem-Behring Corp. | GMM |
| May 7, 1979 | K790556 | CHOLESTEROL REAGENT, AUTOMATED ENZYMATIC Calbiochem-Behring Corp. | CHH |
| Apr 23, 1979 | K790280 | AUTOANTIBODY REAGENTS, AFT SYSTEM II Calbiochem-Behring Corp. | DHN |
| Mar 15, 1979 | K790330 | CALBIOCHEM-BEHRING LASER IMMUNOGLOBULIN Calbiochem-Behring Corp. | JJY |
| Jan 26, 1979 | K790012 | RHEUMOGEN TEST SYSTEM Calbiochem-Behring Corp. | DHR |
| Jan 3, 1979 | K781996 | ACID REAGENT, URIC SINGLE VIAL Calbiochem-Behring Corp. | CDO |
| Oct 3, 1978 | K781527 | RIA SYSTEM FOR HUMAN FE-RITIN Calbiochem-Behring Corp. | JMG |
| Jun 22, 1978 | K780870 | RIA SYSTEM FOR HUMAN F-S HORMONE Calbiochem-Behring Corp. | CGJ |
| Apr 28, 1978 | K780367 | RIA SYS. FOR HUMAN LUTEINIZING HORMONE Calbiochem-Behring Corp. | CEP |
| Apr 12, 1978 | K780347 | RIA SYS. FOR HUMAN GROWTH HORMONE Calbiochem-Behring Corp. | CFL |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||