The following data is part of a premarket notification filed by Irvine Scientific Sales Co., Inc. with the FDA for Embryo Freeze Medium, Embryo Thaw Medium.
| Device ID | K013518 |
| 510k Number | K013518 |
| Device Name: | EMBRYO FREEZE MEDIUM, EMBRYO THAW MEDIUM |
| Classification | Media, Reproductive |
| Applicant | IRVINE SCIENTIFIC SALES CO., INC. 2511 DAIMLER ST. Santa Ana, CA 92705 |
| Contact | Wendell Lee |
| Correspondent | Wendell Lee IRVINE SCIENTIFIC SALES CO., INC. 2511 DAIMLER ST. Santa Ana, CA 92705 |
| Product Code | MQL |
| CFR Regulation Number | 884.6180 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-10-23 |
| Decision Date | 2002-01-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00893727002187 | K013518 | 000 |