Gelman Instrument Co.: FDA filings under this applicant name
FDA lists 11 510(k) clearances under the applicant name “Gelman Instrument Co.” (first 1977, latest 1978), across 11 product codes in 2 review panels. Median 510(k) review time under this name: 92 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 |
|---|---|---|---|
| CJO | Alpha-Naphthyl Phosphate, Alkaline Phosphatase Or Isoenzymes | 1 | 1 |
| CZP | Iga, Antigen, Antiserum, Control | 1 | 1 |
| DAB | Haptoglobin, Fitc, Antigen, Antiserum, Control | 1 | 1 |
| DAY | Complement C5, Antigen, Antiserum, Control | 1 | 1 |
| DBI | Complement C4, Antigen, Antiserum, Control | 1 | 1 |
| DDI | Transferrin, Fitc, Antigen, Antiserum, Control | 1 | 1 |
| DEM | Alpha-1-Antitrypsin, Antigen, Antiserum, Control | 1 | 1 |
| DEW | Igg, Antigen, Antiserum, Control | 1 | 1 |
| DFC | Lipoprotein, Low-Density, Antigen, Antiserum, Control | 1 | 1 |
| DFL | Igm, Ferritin, Antigen, Antiserum, Control | 1 | 1 |
Plus 1 more product codes.
Review panels
- Immunology (9)
- Clinical Chemistry (2)
Most recent Gelman Instrument Co. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K772080 | RADIAL IMMUNODIFFUSION KIT-ALPH-L-ANTIT | DEM | 1978-02-03 | 92 |
| K772079 | RADIAL IMMUNODIFFUSION KIT-IMMUNOGLOB.M | DFL | 1978-02-03 | 92 |
| K772078 | RADIAL IMMUNODIFFUSION KIT-HAPTOGLOBIN | DAB | 1978-02-03 | 92 |
| K772077 | RADIAL IMMUNODIFFUSION KIT-IMMUNOGLOB.G | DEW | 1978-02-03 | 92 |
| K772076 | RADIAL IMMUNODIFFUSION KIT-IMMUNOGLOB. | CZP | 1978-02-03 | 92 |
| K772075 | RADIAL IMMUNODIFFUSION KIT-COMPLEMENT | DAY | 1978-02-03 | 92 |
| K772074 | RADIAL IMMUNODIFFUSION KIT-TRANSFERRIN | DDI | 1978-02-03 | 92 |
| K772073 | RADIAL IMMUNODIFFUSION KIT-COMP. 3 | DBI | 1978-02-03 | 92 |
| K772325 | DENSITOMETER 18, COMPUTING, AUTO. | JQT | 1978-01-12 | 24 |
| K771812 | LIPPOPROTEIN ELECTROPHORESIS REAGENT SET | DFC | 1977-10-18 | 21 |
1 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Gelman Instrument Co..
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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Gelman Sciences, Inc. (32 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Gelman Instrument Co.?
FDA lists 11 510(k) clearances under the applicant name “Gelman Instrument Co.” (first 1977, latest 1978), across 11 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 Gelman Instrument Co.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Gelman Instrument Co. is 92 days.
Which FDA product codes appear under Gelman Instrument Co.?
The most frequent FDA product codes under this applicant name are CJO (Alpha-Naphthyl Phosphate, Alkaline Phosphatase Or Isoenzymes, 1); CZP (Iga, Antigen, Antiserum, Control, 1); DAB (Haptoglobin, Fitc, Antigen, Antiserum, Control, 1).
Next steps
- See all 11 Gelman Instrument Co. clearances with predicates and recalls
- Run predicate analysis for product code CJO, Gelman Instrument Co.'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.