ThermoGenesis Corp.
Rancho Cordova, CA, US
ThermoGenesis Corp. appears in FDA device records in Rancho Cordova, CA. FDA records list 3 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 3 510(k) clearances for ThermoGenesis Corp. between 1996 and 2008. The busiest year on record is 1996, with 1. The most recent is 2008, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1996 | 1 |
| 2007 | 1 |
| 2008 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K081345 | AXP PLATFORM MARROW XPRESS SYSTEM MODEL 8-5137, 8-5138, 8-5139, 8-5140 (PRIMARY) | JQC | Substantially Equivalent for Some Indications | |
| K071126 | CRYOSEAL FS APPLICATOR SYSTEM | FMF | Substantially Equivalent | |
| K955282 | THERMOGENESIS DROP APPLICATOR, KITS, SPRAY KITS AND TIPS | FMF | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2950374 | 1000123765 | ThermoGenesis Corp. | 2890 Kilgore Rd, RANCHO CORDOVA, CA 95670 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain