The following data is part of a premarket notification filed by Newport Biosystems, Inc. with the FDA for Fetal Bovine Serum In Transfer Container.
| Device ID | K853441 |
| 510k Number | K853441 |
| Device Name: | FETAL BOVINE SERUM IN TRANSFER CONTAINER |
| Classification | Flask, Tissue Culture |
| Applicant | NEWPORT BIOSYSTEMS, INC. ROD ROBERTS 150 E. EDINGER, SUITE C Santa Ana, CA 92705 |
| Contact | Cult Innov |
| Correspondent | Cult Innov NEWPORT BIOSYSTEMS, INC. ROD ROBERTS 150 E. EDINGER, SUITE C Santa Ana, CA 92705 |
| Product Code | KJA |
| CFR Regulation Number | 864.2240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-08-13 |
| Decision Date | 1985-08-26 |