Bartels Immunodiagnostic Supplies, Inc.: FDA filings under this applicant name
FDA lists 35 510(k) clearances under the applicant name “Bartels Immunodiagnostic Supplies, Inc.” (first 1981, latest 1986), across 19 product codes in 3 review panels. Median 510(k) review time under this name: 76 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| KIR | Cells, Animal And Human, Cultured | 10 | 10 |
| KIT | Media And Components, Synthetic Cell And Tissue Culture | 5 | 5 |
| KJR | Erythrosin B | 2 | 2 |
| LIN | Antisera, Conjugated Fluorescent, Cytomegalovirus | 2 | 2 |
| CZP | Iga, Antigen, Antiserum, Control | 1 | 1 |
| DEH | Lambda, Antigen, Antiserum, Control | 1 | 1 |
| DEW | Igg, Antigen, Antiserum, Control | 1 | 1 |
| DFH | Kappa, Antigen, Antiserum, Control | 1 | 1 |
| DFT | Igm, Antigen, Antiserum, Control | 1 | 1 |
| GPT | Antiserum, Cf, Psittacosis (Chlamydia Group) | 1 | 1 |
Plus 9 more product codes.
Review panels
- Pathology (18)
- Microbiology (10)
- Immunology (5)
Most recent Bartels Immunodiagnostic Supplies, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K864776 | A549 (HUMAN LUNG CARCINOMA) CULTURE CELLS | KIR | 1986-12-31 | 23 |
| K861172 | ROTAVIRUS LATEX AGGLUTINATION ASSAY | LIQ | 1986-07-01 | 95 |
| K860279 | CYTOMEGALOVIRUS DIRECT FLUORESCENT ANTIBODY KIT | LIN | 1986-05-13 | 119 |
| K855034 | AMERICAN HISTO-ID SYS PRIMARY KIT PSA PROSTATE ANT | LIJ | 1986-03-11 | 84 |
| K842830 | IMMUNOPER-OXIDASE TEST KIT FOR DETECT OF | GQN | 1985-11-26 | 494 |
| K852185 | RESPIRATORY SYNCYTIAL VIRUS DIRECT FLUORESCENT ANT | LKT | 1985-08-19 | 91 |
| K844105 | FITC LABELED CHLAMYDIAE MONOCLONAL ANTIBODY | — | 1984-12-06 | 44 |
| K842834 | HEP-2 CELLS | KJR | 1984-08-28 | 39 |
| K842833 | PMK PRIMARY MONKEY KIDNEY-CELLS | KJR | 1984-08-28 | 39 |
| K842328 | AMER. HISTO-ID SYS PRIMARY LAMBDA CHAIN | DEH | 1984-08-03 | 51 |
25 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Bartels Immunodiagnostic Supplies, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Bartels & Stout, Inc. (3 510(k)s)
- Bartels, Inc. (2 510(k)s)
- Bartels Prognostics, Inc. (0 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Bartels Immunodiagnostic Supplies, Inc.?
FDA lists 35 510(k) clearances under the applicant name “Bartels Immunodiagnostic Supplies, Inc.” (first 1981, latest 1986), across 19 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Bartels Immunodiagnostic Supplies, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Bartels Immunodiagnostic Supplies, Inc. is 76 days.
Which FDA product codes appear under Bartels Immunodiagnostic Supplies, Inc.?
The most frequent FDA product codes under this applicant name are KIR (Cells, Animal And Human, Cultured, 10); KIT (Media And Components, Synthetic Cell And Tissue Culture, 5); KJR (Erythrosin B, 2).
Next steps
- See all 35 Bartels Immunodiagnostic Supplies, Inc. clearances with predicates and recalls
- Run predicate analysis for product code KIR, Bartels Immunodiagnostic Supplies, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.