The following data is part of a premarket notification filed by Hoffmann-la Roche, Inc. with the FDA for Enterotube Ii.
| Device ID | K781236 |
| 510k Number | K781236 |
| Device Name: | ENTEROTUBE II |
| Classification | Kit, Identification, Enterobacteriaceae |
| Applicant | HOFFMANN-LA ROCHE, INC. 340 KINGSLAND ST. Nutley, NJ 07110 -1199 |
| Product Code | JSS |
| CFR Regulation Number | 866.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-07-20 |
| Decision Date | 1978-08-31 |