The following data is part of a premarket notification filed by Irvine Scientific Sales Co., Inc. with the FDA for Dextran Serum Supplement (dss), Model 9301.
| Device ID | K003448 |
| 510k Number | K003448 |
| Device Name: | DEXTRAN SERUM SUPPLEMENT (DSS), MODEL 9301 |
| 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 | 2000-11-06 |
| Decision Date | 2000-12-07 |