The following data is part of a premarket notification filed by Sigma Chemical Co. with the FDA for (s-mem) Auto-mod Product No. M7272.
Device ID | K870481 |
510k Number | K870481 |
Device Name: | (S-MEM) AUTO-MOD PRODUCT NO. M7272 |
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 | 1987-02-03 |
Decision Date | 1987-03-30 |