The following data is part of a premarket notification filed by Sigma Chemical Co. with the FDA for Mcdb 201 Med Cat No. M6770 W/ Hepes & W0/ Bicarbon.
| Device ID | K852568 |
| 510k Number | K852568 |
| Device Name: | MCDB 201 MED CAT NO. M6770 W/ HEPES & W0/ BICARBON |
| Classification | Media And Components, Synthetic Cell And Tissue Culture |
| Applicant | SIGMA CHEMICAL CO. P.O. BOX 14508 St. Louis, MO 63178 |
| Contact | Jan Baker |
| Correspondent | Jan Baker 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 | 1985-06-18 |
| Decision Date | 1985-07-12 |