Kallestad Laboratories, Inc.: FDA clearances and approvals
Kallestad Laboratories, Inc. has 92 FDA 510(k) clearances (first 1976, latest 1986), across 59 product codes in 7 review panels. Median 510(k) review time: 28 days.
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 |
|---|---|---|---|
| DGC | Ige, Antigen, Antiserum, Control | 8 | 8 |
| DHB | System, Test, Radioallergosorbent (Rast) Immunological | 5 | 5 |
| DEH | Lambda, Antigen, Antiserum, Control | 4 | 4 |
| CZP | Iga, Antigen, Antiserum, Control | 3 | 3 |
| DFT | Igm, Antigen, Antiserum, Control | 3 | 3 |
| JZS | Electrophoresis Instrumentation | 3 | 3 |
| CDP | Radioimmunoassay, Total Triiodothyronine | 2 | 2 |
| CZQ | Bence-Jones Protein, Antigen, Antiserum, Control | 2 | 2 |
| DBI | Complement C4, Antigen, Antiserum, Control | 2 | 2 |
| DCE | Fab, Antigen, Antiserum, Control | 2 | 2 |
Plus 49 more product codes.
Review panels
- Immunology (57)
- Clinical Chemistry (14)
- Clinical Toxicology (7)
- Microbiology (6)
- Hematology (2)
- Dental (1)
- Pathology (1)
Most recent Kallestad Laboratories, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K863681 | PATHFINDER(TM) DIRECT ANTIGEN DETECTION SYSTEM | LJP | 1986-12-03 | 75 |
| K862917 | PATHFINDER ROTAVIRUS CHEMILUMINESCENT | LIQ | 1986-10-22 | 82 |
| K863682 | PATHFINDER(TM) SPECIMEN COLLECTION KIT | JSM | 1986-10-10 | 21 |
| K862743 | PATHFINDER(TM) RESPIRATORY SYNCYTIAL VIRUS | GQG | 1986-09-29 | 70 |
| K862313 | KALLESTAD SM/RNP TEST REAGENT | LKJ | 1986-08-06 | 49 |
| K862710 | KALLESTAD SSA/SSB ENA TEST REAGENTS | LLL | 1986-07-29 | 13 |
| K855014 | QUANTIMETRIC PLUS CALIBRATOR/CONTROL SET A | JIX | 1986-03-14 | 88 |
| K855010 | QUANTIMETRIC PLUS IGM REAGENT KIT | DFT | 1986-02-28 | 74 |
| K855013 | QUANTIMETRIC PLUS SUPPORT PACK | DEH | 1986-02-26 | 72 |
| K855012 | QUANTIMETRIC PLUS C4 REAGENT KIT | DBI | 1986-02-26 | 72 |
82 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Kallestad Laboratories, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Kallestad Laboratories, Inc. have?
Kallestad Laboratories, Inc. has 92 FDA 510(k) clearances (first 1976, latest 1986), across 59 product codes in 7 review panels.
How long does FDA take to clear Kallestad Laboratories, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Kallestad Laboratories, Inc.'s cleared 510(k)s is 28 days.
What devices does Kallestad Laboratories, Inc. make?
Its most frequent FDA product codes are DGC (Ige, Antigen, Antiserum, Control, 8); DHB (System, Test, Radioallergosorbent (Rast) Immunological, 5); DEH (Lambda, Antigen, Antiserum, Control, 4).
Has Kallestad Laboratories, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Kallestad Laboratories, Inc. Related entities may recall under other names.
Next steps
- See all 92 Kallestad Laboratories, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DGC, Kallestad Laboratories, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.