Company ยท US
Bartels Immunodiagnostic Supplies, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1981 to 1986. Name variants (Inc, Corp, punctuation) are merged.
35510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| KIR | Cells, Animal And Human, Cultured | 10 |
| KIT | Media And Components, Synthetic Cell And Tissue Culture | 5 |
| KJR | Erythrosin B | 2 |
| LIN | Antisera, Conjugated Fluorescent, Cytomegalovirus | 2 |
| CZP | Iga, Antigen, Antiserum, Control | 1 |
| DEH | Lambda, Antigen, Antiserum, Control | 1 |
| DEW | Igg, Antigen, Antiserum, Control | 1 |
| DFH | Kappa, Antigen, Antiserum, Control | 1 |
| DFT | Igm, Antigen, Antiserum, Control | 1 |
| GPT | Antiserum, Cf, Psittacosis (Chlamydia Group) | 1 |
| GQN | Antigen, Cf (Including Cf Control), Herpesvirus Hominis 1,2 | 1 |
| JSK | Supplement, Culture Media | 1 |
| JSM | Culture Media, Non-Propagating Transport | 1 |
| LIJ | Peroxidase Anti-Peroxidase Immunohistochemical Stain | 1 |
| LIQ | Enzyme Linked Immunoabsorbent Assay, Rotavirus | 1 |
| LKH | Antisera, Immunoperoxidase, Chlamydia Spp. | 1 |
| LKT | Respiratory Syncytial Virus, Antigen, Antibody, Ifa | 1 |
| MCB | Antigen, C. Difficile | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 31, 1986 | K864776 | A549 (HUMAN LUNG CARCINOMA) CULTURE CELLS Bartels Immunodiagnostic Supplies, Inc. | KIR |
| Jul 1, 1986 | K861172 | ROTAVIRUS LATEX AGGLUTINATION ASSAY Bartels Immunodiagnostic Supplies, Inc. | LIQ |
| May 13, 1986 | K860279 | CYTOMEGALOVIRUS DIRECT FLUORESCENT ANTIBODY KIT Bartels Immunodiagnostic Supplies, Inc. | LIN |
| Mar 11, 1986 | K855034 | AMERICAN HISTO-ID SYS PRIMARY KIT PSA PROSTATE ANT Bartels Immunodiagnostic Supplies, Inc. | LIJ |
| Nov 26, 1985 | K842830 | IMMUNOPER-OXIDASE TEST KIT FOR DETECT OF Bartels Immunodiagnostic Supplies, Inc. | GQN |
| Aug 19, 1985 | K852185 | RESPIRATORY SYNCYTIAL VIRUS DIRECT FLUORESCENT ANT Bartels Immunodiagnostic Supplies, Inc. | LKT |
| Dec 6, 1984 | K844105 | FITC LABELED CHLAMYDIAE MONOCLONAL ANTIBODY Bartels Immunodiagnostic Supplies, Inc. | |
| Aug 28, 1984 | K842834 | HEP-2 CELLS Bartels Immunodiagnostic Supplies, Inc. | KJR |
| Aug 28, 1984 | K842833 | PMK PRIMARY MONKEY KIDNEY-CELLS Bartels Immunodiagnostic Supplies, Inc. | KJR |
| Aug 3, 1984 | K842328 | AMER. HISTO-ID SYS PRIMARY LAMBDA CHAIN Bartels Immunodiagnostic Supplies, Inc. | DEH |
| Aug 2, 1984 | K842330 | AMER. HISTO-ID SYS PRIMARY IGA 2720-21 Bartels Immunodiagnostic Supplies, Inc. | CZP |
| Aug 2, 1984 | K842329 | AMER. HISTO-ID SYS PRIMARY IGG S7920-11 Bartels Immunodiagnostic Supplies, Inc. | DEW |
| Aug 2, 1984 | K842327 | AMER. HISTO-ID SYS PRIMARY IGM S7920-31 Bartels Immunodiagnostic Supplies, Inc. | DFT |
| Aug 2, 1984 | K842326 | AMER. HISTO-ID SYS PRIMARY KIT Bartels Immunodiagnostic Supplies, Inc. | DFH |
| Jul 20, 1984 | K842151 | CHLAMYDIAE IMMUNOPEROXIDASE TEST KIT Bartels Immunodiagnostic Supplies, Inc. | LKH |
| Jun 27, 1984 | K841998 | IMR-90-DIPLOID-HUMAN FETAL LUNG CELL Bartels Immunodiagnostic Supplies, Inc. | KIR |
| Jun 22, 1984 | K842000 | PRIMARY RABBITT KIDNEY CELL CULTURE Bartels Immunodiagnostic Supplies, Inc. | KIR |
| Jun 22, 1984 | K841999 | BGM CELL CULTURE AFRICAN GREEN MONKEY Bartels Immunodiagnostic Supplies, Inc. | KIR |
| Jun 7, 1984 | K840744 | TRANSPORTER VIRAL TRANSPORT MEDIUM Bartels Immunodiagnostic Supplies, Inc. | KIT |
| May 21, 1984 | K833447 | CYTOTOXICITY ASSAY FOR CLOSTRIDIUM- Bartels Immunodiagnostic Supplies, Inc. | MCB |
| Apr 20, 1984 | K834116 | DEAE-DEXTRAN IN PBS Bartels Immunodiagnostic Supplies, Inc. | KIT |
| Mar 23, 1984 | K834115 | CULTROL-ANTIBIOTIC/ANTIMYCOTIC SOLUT Bartels Immunodiagnostic Supplies, Inc. | JSK |
| Mar 23, 1984 | K834113 | TISSUE CULTURE REFEEDING MEDIUM Bartels Immunodiagnostic Supplies, Inc. | KIT |
| Mar 22, 1984 | K834136 | PBS W/MG+2 & CA+2 Bartels Immunodiagnostic Supplies, Inc. | KIT |
| Mar 22, 1984 | K834126 | MRC-5 CELLS Bartels Immunodiagnostic Supplies, Inc. | KIR |
| Mar 22, 1984 | K834124 | VERO CELLS Bartels Immunodiagnostic Supplies, Inc. | KIR |
| Mar 22, 1984 | K834123 | WI-38 HUMAN LUNG CELLS Bartels Immunodiagnostic Supplies, Inc. | KIR |
| Mar 22, 1984 | K834120 | LLC-MK2-RHESUS MONKEY KIDNEY CELLS Bartels Immunodiagnostic Supplies, Inc. | KIR |
| Mar 22, 1984 | K834119 | MCCOY CELLS Bartels Immunodiagnostic Supplies, Inc. | KIR |
| Mar 22, 1984 | K834117 | HUMAN FIBROBLASTIC CELLS-HUMAN NEWBORN Bartels Immunodiagnostic Supplies, Inc. | KIR |
| Feb 24, 1984 | K840851 | VIRAL TRANSPORT MEDIUM Bartels Immunodiagnostic Supplies, Inc. | |
| Feb 13, 1984 | K834125 | CHLAMYDIAL TRANSPORT MEDIUM Bartels Immunodiagnostic Supplies, Inc. | JSM |
| Feb 13, 1984 | K834122 | CHLAMYDIAE ISOLATION MEDIUM W/CYCLOHEX Bartels Immunodiagnostic Supplies, Inc. | KIT |
| May 3, 1982 | K820895 | CYLOMEGALOVIRUS DIRECT FLUORESCENT ANTI Bartels Immunodiagnostic Supplies, Inc. | LIN |
| May 5, 1981 | K810856 | DIRECT IMMUNOFLUOR. ANTIBODY TEST KIT Bartels Immunodiagnostic Supplies, Inc. | GPT |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||