The following data is part of a premarket notification filed by Hillcrest Biologicals with the FDA for Chlamydial Transport Media.
| Device ID | K850124 |
| 510k Number | K850124 |
| Device Name: | CHLAMYDIAL TRANSPORT MEDIA |
| Classification | Culture Media, Non-propagating Transport |
| Applicant | HILLCREST BIOLOGICALS 10703 PROGRESS WAY Cypress, CA 90630 |
| Contact | Louis C Cullman |
| Correspondent | Louis C Cullman HILLCREST BIOLOGICALS 10703 PROGRESS WAY Cypress, CA 90630 |
| Product Code | JSM |
| CFR Regulation Number | 866.2390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-01-14 |
| Decision Date | 1985-03-04 |