The following data is part of a premarket notification filed by Invitrocare, Inc. with the FDA for Isocare One Step Sperm Processing Medium Cat# 2207-12.
| Device ID | K023222 |
| 510k Number | K023222 |
| Device Name: | ISOCARE ONE STEP SPERM PROCESSING MEDIUM CAT# 2207-12 |
| Classification | Media, Reproductive |
| Applicant | INVITROCARE, INC. 8415 PROGRESS DRIVE SUITE F Frederick, MD 21701 |
| Contact | Robert E Lovins |
| Correspondent | Robert E Lovins INVITROCARE, INC. 8415 PROGRESS DRIVE SUITE F Frederick, MD 21701 |
| Product Code | MQL |
| CFR Regulation Number | 884.6180 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-09-27 |
| Decision Date | 2002-12-26 |
| Summary: | summary |