Company ยท US
Gelco Diagnostics, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1983 to 1983. Name variants (Inc, Corp, punctuation) are merged.
14510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| CZN | Iga, Fitc, Antigen, Antiserum, Control | 2 |
| DEH | Lambda, Antigen, Antiserum, Control | 2 |
| DEW | Igg, Antigen, Antiserum, Control | 2 |
| DFH | Kappa, Antigen, Antiserum, Control | 2 |
| DFT | Igm, Antigen, Antiserum, Control | 2 |
| CZP | Iga, Antigen, Antiserum, Control | 1 |
| DEO | Kappa, Fitc, Antigen, Antiserum, Control | 1 |
| DES | Lambda, Fitc, Antigen, Antiserum, Control | 1 |
| JBQ | Antithrombin Iii Quantitation | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 31, 1983 | K832270 | GOAT ANTI-HUMAN LAMBA Gelco Diagnostics, Inc. | DEH |
| Oct 31, 1983 | K832267 | FITC GOAT ANTI-HUMAN LAMBA Gelco Diagnostics, Inc. | DES |
| Oct 31, 1983 | K832266 | FITC GOAT ANTI-HUMAN KAPPA AFFINITY Gelco Diagnostics, Inc. | DFH |
| Oct 31, 1983 | K832265 | FITC GOAT ANTI-HUMAN IGM H CHAIN Gelco Diagnostics, Inc. | DFT |
| Oct 31, 1983 | K832263 | FITC GOAT ANTI-HUMAN IGA A CHAIN Gelco Diagnostics, Inc. | CZP |
| Oct 31, 1983 | K832262 | FITC GOAT ANTI-HUMAN IMMUNOGLOBULINS Gelco Diagnostics, Inc. | CZN |
| Oct 31, 1983 | K832260 | GOAT ANTI-HUMAN KAPPA AFFINITY Gelco Diagnostics, Inc. | DEO |
| Oct 31, 1983 | K832258 | GOAT ANTI-HUMAN IGG Y CHAIN SPECIFIC Gelco Diagnostics, Inc. | DEW |
| Oct 31, 1983 | K832256 | GOAT ANTI-HUMAN IMMUNOGLOBULINS- Gelco Diagnostics, Inc. | DFH |
| Oct 28, 1983 | K832264 | FITC GOAT ANTI-HUMAN IGG Y CHAIN Gelco Diagnostics, Inc. | DEW |
| Oct 28, 1983 | K832261 | GOAT ANTI-HUMAN LAMBA AFFINITY Gelco Diagnostics, Inc. | DEH |
| Oct 28, 1983 | K832259 | GOAT ANTI-HUMAN IGM H CHAIN Gelco Diagnostics, Inc. | DFT |
| Oct 28, 1983 | K832257 | GOAT ANTI-HUMAN IGA A CHAIN SPECIFIC Gelco Diagnostics, Inc. | CZN |
| Aug 12, 1983 | K832268 | RABBIT ANTI-HUMAN ANTITHROMBIN III Gelco Diagnostics, Inc. | JBQ |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||