The following data is part of a premarket notification filed by Sigma Chemical Co. with the FDA for Rpmi-1640 Medium No. R7755 Auto-mod(tm) W.o/l-glu..
| Device ID | K873092 |
| 510k Number | K873092 |
| Device Name: | RPMI-1640 MEDIUM NO. R7755 AUTO-MOD(TM) W.O/L-GLU. |
| Classification | Media And Components, Synthetic Cell And Tissue Culture |
| Applicant | SIGMA CHEMICAL CO. P.O. BOX 14508 St. Louis, MO 63178 |
| Contact | David K Bagley |
| Correspondent | David K Bagley SIGMA CHEMICAL CO. P.O. BOX 14508 St. Louis, MO 63178 |
| Product Code | KIT |
| CFR Regulation Number | 864.2220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-08-06 |
| Decision Date | 1987-08-25 |