The following data is part of a premarket notification filed by Irvine Scientific Sales Co., Inc. with the FDA for Pbs 1x- Dulbecco's Phosphate Buffered Saline Solution.
| Device ID | K991342 |
| 510k Number | K991342 |
| Device Name: | PBS 1X- DULBECCO'S PHOSPHATE BUFFERED SALINE SOLUTION |
| 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 | 1999-04-19 |
| Decision Date | 1999-07-08 |
| Summary: | summary |