The following data is part of a premarket notification filed by Syngen, Inc 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 | BK120061 |
| 510k Number | BK120061 |
| 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 | SynGen, Inc 2125 19th Street, Suite 120 Sacramento, CA 95818 |
| Product Code | OAO |
| CFR Regulation Number | 864.9900 [🔎] |
| Decision | Substantially Equivalent (SE) |
| Type | 510(k) Abbrevia |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-10-16 |
| Decision Date | 2013-07-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00886368000643 | BK120061 | 0 |
| 00886368000155 | BK120061 | 0 |
| 00886368000056 | BK120061 | 0 |
| 00886368000193 | BK120061 | 0 |
| 00886368000209 | BK120061 | 0 |
| 00886368000216 | BK120061 | 0 |
| 00886368000223 | BK120061 | 0 |
| 00886368000971 | BK120061 | 0 |
| 00886368000070 | BK120061 | 0 |
| 00886368000094 | BK120061 | 0 |
| 00886368000100 | BK120061 | 0 |
| 00886368000087 | BK120061 | 0 |
| 00886368000124 | BK120061 | 0 |
| 00886368000186 | BK120061 | 0 |
| 00886368000629 | BK120061 | 0 |
| 00886368000605 | BK120061 | 0 |