Gelman Instrument Co.
Mchenry, IL, US
Gelman Instrument Co. appears in FDA device records in Mchenry, IL. FDA records list 11 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 11
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 11 510(k) clearances for Gelman Instrument Co. between 1977 and 1978. The busiest year on record is 1978, with 9. The most recent is 1978, with 9.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1977 | 2 |
| 1978 | 9 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K772080 | RADIAL IMMUNODIFFUSION KIT-ALPH-L-ANTIT | DEM | Substantially Equivalent | |
| K772079 | RADIAL IMMUNODIFFUSION KIT-IMMUNOGLOB.M | DFL | Substantially Equivalent | |
| K772078 | RADIAL IMMUNODIFFUSION KIT-HAPTOGLOBIN | DAB | Substantially Equivalent | |
| K772077 | RADIAL IMMUNODIFFUSION KIT-IMMUNOGLOB.G | DEW | Substantially Equivalent | |
| K772076 | RADIAL IMMUNODIFFUSION KIT-IMMUNOGLOB. | CZP | Substantially Equivalent | |
| K772075 | RADIAL IMMUNODIFFUSION KIT-COMPLEMENT | DAY | Substantially Equivalent | |
| K772074 | RADIAL IMMUNODIFFUSION KIT-TRANSFERRIN | DDI | Substantially Equivalent | |
| K772073 | RADIAL IMMUNODIFFUSION KIT-COMP. 3 | DBI | Substantially Equivalent | |
| K772325 | DENSITOMETER 18, COMPUTING, AUTO. | JQT | Substantially Equivalent | |
| K771812 | LIPPOPROTEIN ELECTROPHORESIS REAGENT SET | DFC | Substantially Equivalent | |
| K770155 | ALKALINE PHOSPHATASE ISOYZME REAGENT SET | CJO | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- DEMAlpha-1-Antitrypsin, Antigen, Antiserum, Control
- CJOAlpha-Naphthyl Phosphate, Alkaline Phosphatase Or Isoenzymes
- DBIComplement C4, Antigen, Antiserum, Control
- DAYComplement C5, Antigen, Antiserum, Control
- JQTDensitometer/Scanner (Integrating, Reflectance, Tlc, Radiochromat.) Clinica
- DABHaptoglobin, Fitc, Antigen, Antiserum, Control
- CZPIga, Antigen, Antiserum, Control
- DEWIgg, Antigen, Antiserum, Control
- DFLIgm, Ferritin, Antigen, Antiserum, Control
- DFCLipoprotein, Low-Density, Antigen, Antiserum, Control
- DDITransferrin, Fitc, Antigen, Antiserum, Control
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain