The following data is part of a premarket notification filed by Prepared Media Laboratory, Inc. with the FDA for Enteric Pathogen Transport (ept) (e1020,e1000).
| Device ID | K962745 |
| 510k Number | K962745 |
| Device Name: | ENTERIC PATHOGEN TRANSPORT (EPT) (E1020,E1000) |
| Classification | Culture Media, Propagating Transport |
| Applicant | PREPARED MEDIA LABORATORY, INC. 15845 SW 72ND AVE. BLDG. C Portland, OR 97224 |
| Contact | Gary Wicklund |
| Correspondent | Gary Wicklund PREPARED MEDIA LABORATORY, INC. 15845 SW 72ND AVE. BLDG. C Portland, OR 97224 |
| Product Code | JSN |
| CFR Regulation Number | 866.2390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-07-15 |
| Decision Date | 1996-10-02 |