The following data is part of a premarket notification filed by Bion Ent., Ltd. with the FDA for Chlamydia (lgv-1).
| Device ID | K894625 |
| 510k Number | K894625 |
| Device Name: | CHLAMYDIA (LGV-1) |
| Classification | Antisera, Fluorescent, Chlamydia Spp. |
| Applicant | BION ENT., LTD. 674 BUSSE HWY. Park Ridge, IL 60068 |
| Contact | Judy Mccormack |
| Correspondent | Judy Mccormack BION ENT., LTD. 674 BUSSE HWY. Park Ridge, IL 60068 |
| Product Code | LKI |
| CFR Regulation Number | 866.3120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-07-20 |
| Decision Date | 1989-08-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B110CHN41100 | K894625 | 000 |
| B110CHM41300 | K894625 | 000 |
| B110CHG41200 | K894625 | 000 |
| B110CH41120 | K894625 | 000 |