Company ยท US
Gelman Instrument Co.
FDA 510(k) clearances and medical device recalls filed under this name, 1977 to 1978. Name variants (Inc, Corp, punctuation) are merged.
11510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| CJO | Alpha-Naphthyl Phosphate, Alkaline Phosphatase Or Isoenzymes | 1 |
| CZP | Iga, Antigen, Antiserum, Control | 1 |
| DAB | Haptoglobin, Fitc, Antigen, Antiserum, Control | 1 |
| DAY | Complement C5, Antigen, Antiserum, Control | 1 |
| DBI | Complement C4, Antigen, Antiserum, Control | 1 |
| DDI | Transferrin, Fitc, Antigen, Antiserum, Control | 1 |
| DEM | Alpha-1-Antitrypsin, Antigen, Antiserum, Control | 1 |
| DEW | Igg, Antigen, Antiserum, Control | 1 |
| DFC | Lipoprotein, Low-Density, Antigen, Antiserum, Control | 1 |
| DFL | Igm, Ferritin, Antigen, Antiserum, Control | 1 |
| JQT | Densitometer/Scanner (Integrating, Reflectance, Tlc, Radiochromat.) Clinica | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 3, 1978 | K772080 | RADIAL IMMUNODIFFUSION KIT-ALPH-L-ANTIT Gelman Instrument Co. | DEM |
| Feb 3, 1978 | K772079 | RADIAL IMMUNODIFFUSION KIT-IMMUNOGLOB.M Gelman Instrument Co. | DFL |
| Feb 3, 1978 | K772078 | RADIAL IMMUNODIFFUSION KIT-HAPTOGLOBIN Gelman Instrument Co. | DAB |
| Feb 3, 1978 | K772077 | RADIAL IMMUNODIFFUSION KIT-IMMUNOGLOB.G Gelman Instrument Co. | DEW |
| Feb 3, 1978 | K772076 | RADIAL IMMUNODIFFUSION KIT-IMMUNOGLOB. Gelman Instrument Co. | CZP |
| Feb 3, 1978 | K772075 | RADIAL IMMUNODIFFUSION KIT-COMPLEMENT Gelman Instrument Co. | DAY |
| Feb 3, 1978 | K772074 | RADIAL IMMUNODIFFUSION KIT-TRANSFERRIN Gelman Instrument Co. | DDI |
| Feb 3, 1978 | K772073 | RADIAL IMMUNODIFFUSION KIT-COMP. 3 Gelman Instrument Co. | DBI |
| Jan 12, 1978 | K772325 | DENSITOMETER 18, COMPUTING, AUTO. Gelman Instrument Co. | JQT |
| Oct 18, 1977 | K771812 | LIPPOPROTEIN ELECTROPHORESIS REAGENT SET Gelman Instrument Co. | DFC |
| Jan 31, 1977 | K770155 | ALKALINE PHOSPHATASE ISOYZME REAGENT SET Gelman Instrument Co. | CJO |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||