510(k) K910108 ยท JIN Nitroprusside, Ketones (Urinary, Non-Quant.)
GDS ENZYMATIC B-HYDROXYBUTYRATE REAGENT MODIFIED
| Applicant | Gds Diagnostics, Elkhart IN, US |
| Decision | Substantially Equivalent, Mar 4, 1991 |
| Received | Jan 10, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K910108
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 12, 2021 | Stanbio Laboratory, LP Beta-Hydroxybutyrate LiquiColor. in vitro diagnostic reagent. Terminated |
JIN | None listed |
| Jul 12, 2021 | Stanbio Laboratory, LP Beta-Hydroxybutyrate Reagent A - Enzyme (unlabeled). in vitro diagnostic reagent. Terminated |
JIN | None listed |
| Jul 12, 2021 | Stanbio Laboratory, LP Synchron CX/DX/LX Beta-Hydroxybutyrate . in vitro diagnostic reagent. Terminated |
JIN | None listed |
| Jul 12, 2021 | Stanbio Laboratory, LP Cardinal Health Beta-Hydroxybutyrate . in vitro diagnostic reagent. Terminated |
JIN | None listed |
| Jul 12, 2021 | Stanbio Laboratory, LP Cardinal Health Beta-Hydroxybutyrate LiquiColor for Synchron CX/LX/DX. in vitro diagnostic reagent. Terminated |
JIN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.