The following data is part of a premarket notification filed by Biocoat, Inc. with the FDA for Picsi Sperm Selection Device.
| Device ID | K052457 |
| 510k Number | K052457 |
| Device Name: | PICSI SPERM SELECTION DEVICE |
| Classification | Labware, Assisted Reproduction |
| Applicant | BIOCOAT, INC. 211 WITMER RD. Horsham, PA 19044 |
| Contact | James B Johnston |
| Correspondent | James B Johnston BIOCOAT, INC. 211 WITMER RD. Horsham, PA 19044 |
| Product Code | MQK |
| CFR Regulation Number | 884.6160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2005-09-07 |
| Decision Date | 2006-04-13 |
| Summary: | summary |