The following data is part of a premarket notification filed by Biogenics, Inc. with the FDA for Biogenics Bioquad 4-well Ivf Culture Dish.
| Device ID | K081896 |
| 510k Number | K081896 |
| Device Name: | BIOGENICS BIOQUAD 4-WELL IVF CULTURE DISH |
| Classification | Labware, Assisted Reproduction |
| Applicant | BIOGENICS, INC. 2797 NAPA VALLEY CORPORATE DR. Napa, CA 94558 |
| Contact | Lou Jones |
| Correspondent | Daniel W Lehtonen INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
| Product Code | MQK |
| CFR Regulation Number | 884.6160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2008-07-03 |
| Decision Date | 2008-08-20 |