Gelco Diagnostics, Inc.: FDA filings under this applicant name
FDA lists 14 510(k) clearances under the applicant name “Gelco Diagnostics, Inc.” (first 1983, latest 1983), across 9 product codes in 2 review panels. Median 510(k) review time under this name: 123 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 |
|---|---|---|---|
| CZN | Iga, Fitc, Antigen, Antiserum, Control | 2 | 2 |
| DEH | Lambda, Antigen, Antiserum, Control | 2 | 2 |
| DEW | Igg, Antigen, Antiserum, Control | 2 | 2 |
| DFH | Kappa, Antigen, Antiserum, Control | 2 | 2 |
| DFT | Igm, Antigen, Antiserum, Control | 2 | 2 |
| CZP | Iga, Antigen, Antiserum, Control | 1 | 1 |
| DEO | Kappa, Fitc, Antigen, Antiserum, Control | 1 | 1 |
| DES | Lambda, Fitc, Antigen, Antiserum, Control | 1 | 1 |
| JBQ | Antithrombin Iii Quantitation | 1 | 1 |
Review panels
- Immunology (13)
- Hematology (1)
Most recent Gelco Diagnostics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K832270 | GOAT ANTI-HUMAN LAMBA | DEH | 1983-10-31 | 123 |
| K832267 | FITC GOAT ANTI-HUMAN LAMBA | DES | 1983-10-31 | 123 |
| K832266 | FITC GOAT ANTI-HUMAN KAPPA AFFINITY | DFH | 1983-10-31 | 123 |
| K832265 | FITC GOAT ANTI-HUMAN IGM H CHAIN | DFT | 1983-10-31 | 123 |
| K832263 | FITC GOAT ANTI-HUMAN IGA A CHAIN | CZP | 1983-10-31 | 123 |
| K832262 | FITC GOAT ANTI-HUMAN IMMUNOGLOBULINS | CZN | 1983-10-31 | 123 |
| K832260 | GOAT ANTI-HUMAN KAPPA AFFINITY | DEO | 1983-10-31 | 123 |
| K832258 | GOAT ANTI-HUMAN IGG Y CHAIN SPECIFIC | DEW | 1983-10-31 | 123 |
| K832256 | GOAT ANTI-HUMAN IMMUNOGLOBULINS- | DFH | 1983-10-31 | 123 |
| K832264 | FITC GOAT ANTI-HUMAN IGG Y CHAIN | DEW | 1983-10-28 | 120 |
4 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Gelco Diagnostics, 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.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Gelco Diagnostics, Inc. (a text match, not an official crosswalk):
Frequently asked questions
How many FDA 510(k) clearances are listed under Gelco Diagnostics, Inc.?
FDA lists 14 510(k) clearances under the applicant name “Gelco Diagnostics, Inc.” (first 1983, latest 1983), across 9 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 Gelco Diagnostics, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Gelco Diagnostics, Inc. is 123 days.
Which FDA product codes appear under Gelco Diagnostics, Inc.?
The most frequent FDA product codes under this applicant name are CZN (Iga, Fitc, Antigen, Antiserum, Control, 2); DEH (Lambda, Antigen, Antiserum, Control, 2); DEW (Igg, Antigen, Antiserum, Control, 2).
Next steps
- See all 14 Gelco Diagnostics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code CZN, Gelco Diagnostics, 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.