The following data is part of a premarket notification filed by Newport Biosystems, Inc. with the FDA for Rpmi 1640 W/glutamine W/hepes.
| Device ID | K860282 |
| 510k Number | K860282 |
| Device Name: | RPMI 1640 W/GLUTAMINE W/HEPES |
| Classification | Media And Components, Synthetic Cell And 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 | KIT |
| CFR Regulation Number | 864.2220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-01-28 |
| Decision Date | 1986-02-05 |