Kallestad Diag, A Div. of Erbamont, Inc.: FDA filings under this applicant name
FDA lists 58 510(k) clearances under the applicant name “Kallestad Diag, A Div. of Erbamont, Inc.” (first 1987, latest 1991), across 38 product codes in 5 review panels. Median 510(k) review time under this name: 40 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 |
|---|---|---|---|
| DCF | Albumin, Antigen, Antiserum, Control | 4 | 4 |
| LJC | Enzyme Linked Immunoabsorbent Assay, (Chlamydiae Group) | 4 | 4 |
| DHR | System, Test, Rheumatoid Factor | 3 | 3 |
| GTQ | Antistreptolysin - Titer/Streptolysin O Reagent | 3 | 3 |
| DCK | C-Reactive Protein, Antigen, Antiserum, And Control | 2 | 2 |
| DCN | System, Test, C-Reactive Protein | 2 | 2 |
| DEM | Alpha-1-Antitrypsin, Antigen, Antiserum, Control | 2 | 2 |
| DEW | Igg, Antigen, Antiserum, Control | 2 | 2 |
| DFC | Lipoprotein, Low-Density, Antigen, Antiserum, Control | 2 | 2 |
| JIX | Calibrator, Multi-Analyte Mixture | 2 | 2 |
Plus 28 more product codes.
Review panels
- Immunology (33)
- Microbiology (13)
- Clinical Chemistry (10)
- Hematology (1)
- Clinical Toxicology (1)
Most recent Kallestad Diag, A Div. of Erbamont, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K910887 | QM300 CONTROL G PACK | GTQ | 1991-06-17 | 105 |
| K910886 | QM300 ANTISTREPTOLYSIN O (ASO) ANTIGEN PACK | GTQ | 1991-06-17 | 105 |
| K910885 | QM300 CALIBRATOR G PACK | GTQ | 1991-06-17 | 105 |
| K904725 | CHLAMYDIA SYSTEM SOFTWARE (CSS) | LJC | 1991-01-14 | 89 |
| K902253 | PATHFINDER(TM) CHLAMYDIA MICROPLATE KIT | LJC | 1990-07-26 | 66 |
| K902462 | MODIFIED QM300 RHEUMATOID FACTOR TEST | DHR | 1990-06-21 | 17 |
| K900010 | NDS CORTISOL TEST KIT AND NDS CORTISOL CALIBRATOR | JFT | 1990-04-03 | 91 |
| K900009 | NDS THEOPHYLLINE TEST KIT & NDS TDM CALIBRATOR SET | KLS | 1990-03-29 | 86 |
| K897072 | NDS THYROXINE TEST KIT & NDS THYROXINE CALIBRATOR | KLI | 1990-03-29 | 97 |
| K894947 | PLATELIA TOXO IGG KIT | LGO | 1990-03-23 | 232 |
48 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Kallestad Diag, A Div. of Erbamont, 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.
- Kallestad Laboratories, Inc. (92 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Kallestad Diag, A Div. of Erbamont, Inc.?
FDA lists 58 510(k) clearances under the applicant name “Kallestad Diag, A Div. of Erbamont, Inc.” (first 1987, latest 1991), across 38 product codes in 5 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 Kallestad Diag, A Div. of Erbamont, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Kallestad Diag, A Div. of Erbamont, Inc. is 40 days.
Which FDA product codes appear under Kallestad Diag, A Div. of Erbamont, Inc.?
The most frequent FDA product codes under this applicant name are DCF (Albumin, Antigen, Antiserum, Control, 4); LJC (Enzyme Linked Immunoabsorbent Assay, (Chlamydiae Group), 4); DHR (System, Test, Rheumatoid Factor, 3).
Next steps
- See all 58 Kallestad Diag, A Div. of Erbamont, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DCF, Kallestad Diag, A Div. of Erbamont, 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, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.