The following data is part of a premarket notification filed by Proteins Intl., Inc. with the FDA for Cytoquant Chlamydia Transport Medium.
| Device ID | K961755 |
| 510k Number | K961755 |
| Device Name: | CYTOQUANT CHLAMYDIA TRANSPORT MEDIUM |
| Classification | Culture Media, Propagating Transport |
| Applicant | PROTEINS INTL., INC. 1858 STAR BATT DR. Rochester Hills, MI 48309 |
| Contact | Naomi Eliezer |
| Correspondent | Naomi Eliezer PROTEINS INTL., INC. 1858 STAR BATT DR. Rochester Hills, MI 48309 |
| Product Code | JSN |
| CFR Regulation Number | 866.2390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-05-06 |
| Decision Date | 1996-05-17 |
| Summary: | summary |