The following data is part of a premarket notification filed by Thermogenesis with the FDA for 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.s. Food & Drug Administration Follow Fda En Español Search Fda Home Food Drugs Medical Devices .
| Device ID | BK070006 |
| 510k Number | BK070006 |
| Device Name: | 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices |
| Classification | Cord Blood Processing System And Storage Container |
| Applicant | Thermogenesis 2711 Citrus Road Rancho Cordova, CA 95742 |
| Product Code | OAO |
| CFR Regulation Number | 864.9900 [🔎] |
| Decision | Substantially Equivalent (SE) |
| Type | 510(k) Traditio |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-02-08 |
| Decision Date | 2007-10-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00088636800438 | BK070006 | 0 |
| 10886368000305 | BK070006 | 0 |
| 20886368000326 | BK070006 | 0 |
| 00886368000346 | BK070006 | 0 |
| 00886368000360 | BK070006 | 0 |
| 00886368000377 | BK070006 | 0 |
| 00886368000407 | BK070006 | 0 |
| 00886368000414 | BK070006 | 0 |
| 00886368000421 | BK070006 | 0 |
| 00886368000445 | BK070006 | 0 |
| 00886368000513 | BK070006 | 0 |
| 00886368000520 | BK070006 | 0 |
| 00886368000537 | BK070006 | 0 |
| 00886368000568 | BK070006 | 0 |
| 00886368000438 | BK070006 | 0 |