Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Bartels Immunodiagnostic Supplies, Inc. · Predicate Candidate Screening
35 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
76 daysmedian FDA review time
119 days90th percentile
35clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K864776 | A549 (HUMAN LUNG CARCINOMA) CULTURE CELLS | Bartels Immunodiagnostic Supplies, Inc. | 1986-12-31 | 23 | 0 |
| K861172 | ROTAVIRUS LATEX AGGLUTINATION ASSAY | Bartels Immunodiagnostic Supplies, Inc. | 1986-07-01 | 95 | 0 |
| K860279 | CYTOMEGALOVIRUS DIRECT FLUORESCENT ANTIBODY KIT | Bartels Immunodiagnostic Supplies, Inc. | 1986-05-13 | 119 | 0 |
| K855034 | AMERICAN HISTO-ID SYS PRIMARY KIT PSA PROSTATE ANT | Bartels Immunodiagnostic Supplies, Inc. | 1986-03-11 | 84 | 0 |
| K842830 | IMMUNOPER-OXIDASE TEST KIT FOR DETECT OF | Bartels Immunodiagnostic Supplies, Inc. | 1985-11-26 | 494 | 0 |
| K852185 | RESPIRATORY SYNCYTIAL VIRUS DIRECT FLUORESCENT ANT | Bartels Immunodiagnostic Supplies, Inc. | 1985-08-19 | 91 | 0 |
| K844105 | FITC LABELED CHLAMYDIAE MONOCLONAL ANTIBODY | Bartels Immunodiagnostic Supplies, Inc. | 1984-12-06 | 44 | 0 |
| K842833 | PMK PRIMARY MONKEY KIDNEY-CELLS | Bartels Immunodiagnostic Supplies, Inc. | 1984-08-28 | 39 | 0 |
| K842834 | HEP-2 CELLS | Bartels Immunodiagnostic Supplies, Inc. | 1984-08-28 | 39 | 0 |
| K842328 | AMER. HISTO-ID SYS PRIMARY LAMBDA CHAIN | Bartels Immunodiagnostic Supplies, Inc. | 1984-08-03 | 51 | 0 |
| K842327 | AMER. HISTO-ID SYS PRIMARY IGM S7920-31 | Bartels Immunodiagnostic Supplies, Inc. | 1984-08-02 | 50 | 0 |
| K842329 | AMER. HISTO-ID SYS PRIMARY IGG S7920-11 | Bartels Immunodiagnostic Supplies, Inc. | 1984-08-02 | 50 | 0 |
| K842326 | AMER. HISTO-ID SYS PRIMARY KIT | Bartels Immunodiagnostic Supplies, Inc. | 1984-08-02 | 50 | 0 |
| K842330 | AMER. HISTO-ID SYS PRIMARY IGA 2720-21 | Bartels Immunodiagnostic Supplies, Inc. | 1984-08-02 | 50 | 0 |
| K842151 | CHLAMYDIAE IMMUNOPEROXIDASE TEST KIT | Bartels Immunodiagnostic Supplies, Inc. | 1984-07-20 | 51 | 0 |
| K841998 | IMR-90-DIPLOID-HUMAN FETAL LUNG CELL | Bartels Immunodiagnostic Supplies, Inc. | 1984-06-27 | 42 | 0 |
| K842000 | PRIMARY RABBITT KIDNEY CELL CULTURE | Bartels Immunodiagnostic Supplies, Inc. | 1984-06-22 | 37 | 0 |
| K841999 | BGM CELL CULTURE AFRICAN GREEN MONKEY | Bartels Immunodiagnostic Supplies, Inc. | 1984-06-22 | 37 | 0 |
| K840744 | TRANSPORTER VIRAL TRANSPORT MEDIUM | Bartels Immunodiagnostic Supplies, Inc. | 1984-06-07 | 105 | 0 |
| K833447 | CYTOTOXICITY ASSAY FOR CLOSTRIDIUM- | Bartels Immunodiagnostic Supplies, Inc. | 1984-05-21 | 229 | 0 |
| K834116 | DEAE-DEXTRAN IN PBS | Bartels Immunodiagnostic Supplies, Inc. | 1984-04-20 | 143 | 0 |
| K834113 | TISSUE CULTURE REFEEDING MEDIUM | Bartels Immunodiagnostic Supplies, Inc. | 1984-03-23 | 115 | 0 |
| K834115 | CULTROL-ANTIBIOTIC/ANTIMYCOTIC SOLUT | Bartels Immunodiagnostic Supplies, Inc. | 1984-03-23 | 115 | 0 |
| K834136 | PBS W/MG+2 & CA+2 | Bartels Immunodiagnostic Supplies, Inc. | 1984-03-22 | 113 | 0 |
| K834119 | MCCOY CELLS | Bartels Immunodiagnostic Supplies, Inc. | 1984-03-22 | 114 | 0 |
| K834124 | VERO CELLS | Bartels Immunodiagnostic Supplies, Inc. | 1984-03-22 | 114 | 0 |
| K834126 | MRC-5 CELLS | Bartels Immunodiagnostic Supplies, Inc. | 1984-03-22 | 114 | 0 |
| K834120 | LLC-MK2-RHESUS MONKEY KIDNEY CELLS | Bartels Immunodiagnostic Supplies, Inc. | 1984-03-22 | 114 | 0 |
| K834123 | WI-38 HUMAN LUNG CELLS | Bartels Immunodiagnostic Supplies, Inc. | 1984-03-22 | 114 | 0 |
| K834117 | HUMAN FIBROBLASTIC CELLS-HUMAN NEWBORN | Bartels Immunodiagnostic Supplies, Inc. | 1984-03-22 | 114 | 0 |
| K840851 | VIRAL TRANSPORT MEDIUM | Bartels Immunodiagnostic Supplies, Inc. | 1984-02-24 | 0 | 0 |
| K834125 | CHLAMYDIAL TRANSPORT MEDIUM | Bartels Immunodiagnostic Supplies, Inc. | 1984-02-13 | 76 | 0 |
| K834122 | CHLAMYDIAE ISOLATION MEDIUM W/CYCLOHEX | Bartels Immunodiagnostic Supplies, Inc. | 1984-02-13 | 76 | 0 |
| K820895 | CYLOMEGALOVIRUS DIRECT FLUORESCENT ANTI | Bartels Immunodiagnostic Supplies, Inc. | 1982-05-03 | 34 | 0 |
| K810856 | DIRECT IMMUNOFLUOR. ANTIBODY TEST KIT | Bartels Immunodiagnostic Supplies, Inc. | 1981-05-05 | 36 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda