The following data is part of a premarket notification filed by Irvine Scientific Sales Co., Inc. with the FDA for Vit Kit - Freeze And Thaw.
| Device ID | K093273 |
| 510k Number | K093273 |
| Device Name: | VIT KIT - FREEZE AND THAW |
| Classification | Media, Reproductive |
| Applicant | IRVINE SCIENTIFIC SALES CO., INC. 2511 DAIMLER ST Santa Ana, CA 92705 |
| Contact | Jayme Yamaguchi-owens |
| Correspondent | Jayme Yamaguchi-owens 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 | 2009-10-19 |
| Decision Date | 2010-03-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00857515006191 | K093273 | 000 |
| 00857515006184 | K093273 | 000 |
| 00857515006177 | K093273 | 000 |
| 00857515006092 | K093273 | 000 |
| 00857515006085 | K093273 | 000 |