The following data is part of a premarket notification filed by Sigma Chemical Co. with the FDA for Ames' Medium No. A1420 W/l-gluta. W.o/sod. Bicarb..
Device ID | K873091 |
510k Number | K873091 |
Device Name: | AMES' MEDIUM NO. A1420 W/L-GLUTA. W.O/SOD. BICARB. |
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 |