The following data is part of a premarket notification filed by Irvine Scientific Sales Co., Inc. with the FDA for Freezing Medium - Test Yolk Buffer (tyb) With Glycerol, Refrigeration Medium - Test Yolk Buffer 9tyb).
| Device ID | K991421 |
| 510k Number | K991421 |
| Device Name: | FREEZING MEDIUM - TEST YOLK BUFFER (TYB) WITH GLYCEROL, REFRIGERATION MEDIUM - TEST YOLK BUFFER 9TYB) |
| Classification | Media, Reproductive |
| Applicant | IRVINE SCIENTIFIC SALES CO., INC. 2511 DAIMLER ST. Santa Ana, CA 92705 |
| Contact | Roberta L Johnson |
| Correspondent | Roberta L Johnson 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 | 1999-04-23 |
| Decision Date | 1999-07-02 |
| Summary: | summary |