Genetic Systems Corp.: FDA clearances and approvals
Genetic Systems Corp. has 12 FDA 510(k) clearances (first 1984, latest 1989), across 6 product codes in 2 review panels. Median 510(k) review time: 38 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 |
|---|---|---|---|
| JTC | Device, Microtiter Diluting/Dispensing | 4 | 4 |
| JJQ | Colorimeter, Photometer, Spectrophotometer For Clinical Use | 2 | 2 |
| LHL | Reagents, Antibody, Legionella, Direct & Indirect Fluorescent | 2 | 2 |
| LKT | Respiratory Syncytial Virus, Antigen, Antibody, Ifa | 2 | 2 |
| CKA | Nadh Oxidation/Nad Reduction, Alt/Sgpt | 1 | 1 |
| LYF | Pneumocystis Carinii | 1 | 1 |
Review panels
- Microbiology (9)
- Clinical Chemistry (3)
Most recent Genetic Systems Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K891767 | GENETIC SYSTEMS MICROPLATE READER | JJQ | 1989-07-25 | 123 |
| K891768 | GENETIC SYSTEMS MICROPLATE WASHER | JTC | 1989-05-01 | 38 |
| K891766 | GENETIC SYSTEMS MICROPLATE STRIP WASHER | JTC | 1989-05-01 | 38 |
| K891765 | GENETIC SYSTEMS PIPETTOR/DILUTOR | JTC | 1989-05-01 | 38 |
| K890768 | PNEUMOCYSTIS CARINII IMMUNOFLUORESCENCE TEST KIT | LYF | 1989-03-21 | 34 |
| K873564 | GENETIC SYSTEMS RSV REAGENT CONTROL SLIDES | LKT | 1987-11-20 | 79 |
| K873542 | MICROPLATE AUTO-WASHER (MOTORIZED STAGE) | JTC | 1987-09-23 | 22 |
| K870176 | GENETIC SYSTEMS RSV IMMUNOFLUORESCENCE TEST KIT | LKT | 1987-07-16 | 182 |
| K870879 | ALANINE TRANSAMINASE (ALT) TEST KIT | CKA | 1987-03-19 | 15 |
| K863566 | GSC 1000 | JJQ | 1986-10-16 | 34 |
2 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Genetic Systems Corp..
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 Genetic Systems Corp. have?
Genetic Systems Corp. has 12 FDA 510(k) clearances (first 1984, latest 1989), across 6 product codes in 2 review panels.
How long does FDA take to clear Genetic Systems Corp.'s 510(k)s?
The median time from FDA receipt to decision across Genetic Systems Corp.'s cleared 510(k)s is 38 days.
What devices does Genetic Systems Corp. make?
Its most frequent FDA product codes are JTC (Device, Microtiter Diluting/Dispensing, 4); JJQ (Colorimeter, Photometer, Spectrophotometer For Clinical Use, 2); LHL (Reagents, Antibody, Legionella, Direct & Indirect Fluorescent, 2).
Has Genetic Systems Corp. had device recalls?
openFDA lists no recalls under a recalling firm name matching Genetic Systems Corp. Related entities may recall under other names.
Next steps
- See all 12 Genetic Systems Corp. clearances with predicates and recalls
- Run predicate analysis for product code JTC, Genetic Systems Corp.'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.