Gelco Diagnostics, Inc.
Mchenry, IL, US
Gelco Diagnostics, Inc. appears in FDA device records in Mchenry, IL. FDA records list 14 510(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
- 14
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 14 510(k) clearances for Gelco Diagnostics, Inc. in 1983.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1983 | 14 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K832270 | GOAT ANTI-HUMAN LAMBA | DEH | Substantially Equivalent | |
| K832267 | FITC GOAT ANTI-HUMAN LAMBA | DES | Substantially Equivalent | |
| K832266 | FITC GOAT ANTI-HUMAN KAPPA AFFINITY | DFH | Substantially Equivalent | |
| K832265 | FITC GOAT ANTI-HUMAN IGM H CHAIN | DFT | Substantially Equivalent | |
| K832263 | FITC GOAT ANTI-HUMAN IGA A CHAIN | CZP | Substantially Equivalent | |
| K832262 | FITC GOAT ANTI-HUMAN IMMUNOGLOBULINS | CZN | Substantially Equivalent | |
| K832260 | GOAT ANTI-HUMAN KAPPA AFFINITY | DEO | Substantially Equivalent | |
| K832258 | GOAT ANTI-HUMAN IGG Y CHAIN SPECIFIC | DEW | Substantially Equivalent | |
| K832256 | GOAT ANTI-HUMAN IMMUNOGLOBULINS- | DFH | Substantially Equivalent | |
| K832264 | FITC GOAT ANTI-HUMAN IGG Y CHAIN | DEW | Substantially Equivalent | |
| K832261 | GOAT ANTI-HUMAN LAMBA AFFINITY | DEH | Substantially Equivalent | |
| K832259 | GOAT ANTI-HUMAN IGM H CHAIN | DFT | Substantially Equivalent | |
| K832257 | GOAT ANTI-HUMAN IGA A CHAIN SPECIFIC | CZN | Substantially Equivalent | |
| K832268 | RABBIT ANTI-HUMAN ANTITHROMBIN III | JBQ | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- JBQAntithrombin Iii Quantitation
- CZPIga, Antigen, Antiserum, Control
- CZNIga, Fitc, Antigen, Antiserum, Control
- DEWIgg, Antigen, Antiserum, Control
- DFTIgm, Antigen, Antiserum, Control
- DFHKappa, Antigen, Antiserum, Control
- DEOKappa, Fitc, Antigen, Antiserum, Control
- DEHLambda, Antigen, Antiserum, Control
- DESLambda, Fitc, Antigen, Antiserum, Control
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
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Data as of , FDA export datePage updated Source: openFDA, public domain