The following data is part of a premarket notification filed by Sigma Chemical Co. with the FDA for Crcm-30 Medium Product No. C5030.
Device ID | K851604 |
510k Number | K851604 |
Device Name: | CRCM-30 MEDIUM PRODUCT NO. C5030 |
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 | 1985-04-16 |
Decision Date | 1985-05-15 |