The following data is part of a premarket notification filed by Sigma Chemical Co. with the FDA for (dmf/f-12) Hybri-max(tm) W/l-glutamine.
| Device ID | K871191 |
| 510k Number | K871191 |
| Device Name: | (DMF/F-12) HYBRI-MAX(TM) W/L-GLUTAMINE |
| Classification | Media And Components, Synthetic Cell And Tissue Culture |
| Applicant | SIGMA CHEMICAL CO. P.O. BOX 14508 St. Louis, MO 63178 |
| Contact | David Bagley |
| Correspondent | David 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 | 1987-03-24 |
| Decision Date | 1987-04-03 |