The following data is part of a premarket notification filed by Rantran, Inc. with the FDA for Rambach Agar.
| Device ID | K912924 |
| 510k Number | K912924 |
| Device Name: | RAMBACH AGAR |
| Classification | Kit, Identification, Enterobacteriaceae |
| Applicant | RANTRAN, INC. 2624 BEAVER GLEN DR. Ashland, VA 23005 |
| Contact | Ed Ransom |
| Correspondent | Ed Ransom RANTRAN, INC. 2624 BEAVER GLEN DR. Ashland, VA 23005 |
| Product Code | JSS |
| CFR Regulation Number | 866.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-07-03 |
| Decision Date | 1992-02-28 |