The following data is part of a premarket notification filed by Gibco Laboratories Life Technologies, Inc. with the FDA for Sorbitol Macconkey (smac) Agar, Dri & Pre-form.
| Device ID | K871855 |
| 510k Number | K871855 |
| Device Name: | SORBITOL MACCONKEY (SMAC) AGAR, DRI & PRE-FORM |
| Classification | Culture Media, Non-selective And Differential |
| Applicant | GIBCO LABORATORIES LIFE TECHNOLOGIES, INC. 2801 INDUSTRIAL DR. Madison, WI 53713 |
| Contact | Gregg G Burmeister |
| Correspondent | Gregg G Burmeister GIBCO LABORATORIES LIFE TECHNOLOGIES, INC. 2801 INDUSTRIAL DR. Madison, WI 53713 |
| Product Code | JSH |
| CFR Regulation Number | 866.2320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-05-13 |
| Decision Date | 1987-05-26 |