Gelco Diagnostics, Inc.
Medical device manufacturer in Walker, MI.
14510(k) clearances
0PMA approvals
0recalls
Device types
- CZN Iga, Fitc, Antigen, Antiserum, Control 2
- DFT Igm, Antigen, Antiserum, Control 2
- DEH Lambda, Antigen, Antiserum, Control 2
- DEW Igg, Antigen, Antiserum, Control 2
- DFH Kappa, Antigen, Antiserum, Control 2
- JBQ Antithrombin Iii Quantitation 1
- DEO Kappa, Fitc, Antigen, Antiserum, Control 1
- CZP Iga, Antigen, Antiserum, Control 1
- DES Lambda, Fitc, Antigen, Antiserum, Control 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K832270 | Goat Anti-Human LambaDEH · Traditional | 10/31/1983SE |
| K832267 | Fitc Goat Anti-Human LambaDES · Traditional | 10/31/1983SE |
| K832266 | Fitc Goat Anti-Human Kappa AffinityDFH · Traditional | 10/31/1983SE |
| K832265 | Fitc Goat Anti-Human Igm H ChainDFT · Traditional | 10/31/1983SE |
| K832263 | Fitc Goat Anti-Human Iga a ChainCZP · Traditional | 10/31/1983SE |
| K832262 | Fitc Goat Anti-Human ImmunoglobulinsCZN · Traditional | 10/31/1983SE |
| K832260 | Goat Anti-Human Kappa AffinityDEO · Traditional | 10/31/1983SE |
| K832258 | Goat Anti-Human Igg Y Chain SpecificDEW · Traditional | 10/31/1983SE |
| K832256 | Goat Anti-Human Immunoglobulins-DFH · Traditional | 10/31/1983SE |
| K832264 | Fitc Goat Anti-Human Igg Y ChainDEW · Traditional | 10/28/1983SE |
| K832261 | Goat Anti-Human Lamba AffinityDEH · Traditional | 10/28/1983SE |
| K832259 | Goat Anti-Human Igm H ChainDFT · Traditional | 10/28/1983SE |
| K832257 | Goat Anti-Human Iga a Chain SpecificCZN · Traditional | 10/28/1983SE |
| K832268 | Rabbit Anti-Human Antithrombin IIIJBQ · Traditional | 08/12/1983SE |