The following data is part of a premarket notification filed by Sigma Chemical Co. with the FDA for Krebs-henseleit Bicarbonate Buffer No. K3753.
| Device ID | K882965 |
| 510k Number | K882965 |
| Device Name: | KREBS-HENSELEIT BICARBONATE BUFFER NO. K3753 |
| Classification | Media And Components, Synthetic Cell And Tissue Culture |
| Applicant | SIGMA CHEMICAL CO. P.O. BOX 14508 St. Louis, MO 63178 |
| Contact | Richard M Noble |
| Correspondent | Richard M Noble 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 | 1988-07-15 |
| Decision Date | 1988-08-04 |