Geometric Data, Div. Smithkline Corp.: FDA filings under this applicant name
FDA lists 18 510(k) clearances under the applicant name “Geometric Data, Div. Smithkline Corp.” (first 1976, latest 1984), across 6 product codes in 2 review panels. Median 510(k) review time under this name: 65 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 |
|---|---|---|---|
| GKZ | Counter, Differential Cell | 11 | 11 |
| GKJ | Spinner, Slide, Automated | 2 | 2 |
| KQC | Stains, Hematology | 2 | 2 |
| GJH | Stain, Reticulocyte | 1 | 1 |
| JOY | Device, Automated Cell-Locating | 1 | 1 |
Plus 1 more product codes.
Review panels
- Hematology (15)
- Pathology (2)
Most recent Geometric Data, Div. Smithkline Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K841852 | AUTOLYZER 800 | GKZ | 1984-09-05 | 125 |
| K811534 | HEMASPINNER | GKJ | 1981-08-18 | 78 |
| K791041 | HEMATRAK ABNORMAL RECOGNITION | GKZ | 1979-09-04 | 91 |
| K791108 | CONTEXT FILTER | GKZ | 1979-07-17 | 33 |
| K790816 | HEMATRAK MODEL 480 | GKZ | 1979-07-17 | 81 |
| K790042 | STAIN, HEMASTAIN RETIC | GJH | 1979-02-15 | 41 |
| K780577 | PLATELETS/CU MM | GKZ | 1978-05-19 | 39 |
| K772139 | RE-CELL SLIDE RECAP | JOY | 1978-01-05 | 52 |
| K761207 | HEMATRAK RBC MORPHOLOGY | GKZ | 1977-10-18 | 315 |
| K770680 | HEMATRAK | GKZ | 1977-07-01 | 81 |
8 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Geometric Data, Div. Smithkline Corp..
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Geometric Data, Div. Smithkline Corp.?
FDA lists 18 510(k) clearances under the applicant name “Geometric Data, Div. Smithkline Corp.” (first 1976, latest 1984), across 6 product codes in 2 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 Geometric Data, Div. Smithkline Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Geometric Data, Div. Smithkline Corp. is 65 days.
Which FDA product codes appear under Geometric Data, Div. Smithkline Corp.?
The most frequent FDA product codes under this applicant name are GKZ (Counter, Differential Cell, 11); GKJ (Spinner, Slide, Automated, 2); KQC (Stains, Hematology, 2).
Next steps
- See all 18 Geometric Data, Div. Smithkline Corp. clearances with predicates and recalls
- Run predicate analysis for product code GKZ, Geometric Data, Div. Smithkline Corp.'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.