Gds Technology, LLC: FDA clearances and approvals
Gds Technology, LLC has 8 FDA 510(k) clearances (first 1988, latest 2002), across 6 product codes in 3 review panels. Median 510(k) review time: 64 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 |
|---|---|---|---|
| KHG | Whole Blood Hemoglobin Determination | 3 | 3 |
| CGA | Glucose Oxidase, Glucose | 1 | 1 |
| CHH | Enzymatic Esterase--Oxidase, Cholesterol | 1 | 1 |
| DKJ | Colorimetry, Salicylate | 1 | 1 |
| JIN | Nitroprusside, Ketones (Urinary, Non-Quant.) | 1 | 1 |
| LDP | Colorimetry, Acetaminophen | 1 | 1 |
Review panels
- Clinical Chemistry (3)
- Hematology (3)
- Clinical Toxicology (2)
Most recent Gds Technology, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K020138 | STAT-SITE MHGB METER, STAT-SITE MHGB METER CARD HOLDER, STAT-SITE MHGB TEST CARDS, STAT-SITE MHGB CODE WAY, MODELS 90090 | KHG | 2002-02-11 | 26 |
| K994073 | HEMOSITE TEST SYSTEM | KHG | 2000-01-14 | 43 |
| K992132 | CHOLESITE TEST SYSTEM | CHH | 1999-08-20 | 58 |
| K973649 | HEMOSITE TEST SYSTEM | KHG | 1998-08-31 | 340 |
| K971145 | GLUCOSITE TEST SYSTEM | CGA | 1997-09-17 | 173 |
| K911801 | KETOSITE(TM)/STAT-SITE(TM)/KETOSITE(TM) LOW-HI CON | JIN | 1991-07-01 | 69 |
| K882038 | GDS ENZYMATIC SALICYLATE REAGENT | DKJ | 1988-06-24 | 39 |
| K880829 | GDS ENZYMATIC ACETAMINOPHEN REAGENT | LDP | 1988-05-27 | 87 |
Recalls
openFDA lists no recalls under a recalling firm named Gds Technology, LLC.
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 Gds Technology, LLC have?
Gds Technology, LLC has 8 FDA 510(k) clearances (first 1988, latest 2002), across 6 product codes in 3 review panels.
How long does FDA take to clear Gds Technology, LLC's 510(k)s?
The median time from FDA receipt to decision across Gds Technology, LLC's cleared 510(k)s is 64 days.
What devices does Gds Technology, LLC make?
Its most frequent FDA product codes are KHG (Whole Blood Hemoglobin Determination, 3); CGA (Glucose Oxidase, Glucose, 1); CHH (Enzymatic Esterase--Oxidase, Cholesterol, 1).
Has Gds Technology, LLC had device recalls?
openFDA lists no recalls under a recalling firm name matching Gds Technology, LLC. Related entities may recall under other names.
Next steps
- See all 8 Gds Technology, LLC clearances with predicates and recalls
- Run predicate analysis for product code KHG, Gds Technology, LLC'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.