The following data is part of a premarket notification filed by Irvine Scientific Sales Co., Inc. with the FDA for Lyophilized Early Cleavage Medium (ecm) Kit.
| Device ID | K072607 |
| 510k Number | K072607 |
| Device Name: | LYOPHILIZED EARLY CLEAVAGE MEDIUM (ECM) KIT |
| 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 | 2007-09-17 |
| Decision Date | 2008-01-25 |
| Summary: | summary |