The following data is part of a premarket notification filed by Seragen Diagnostics, Inc. with the FDA for Vivid Chlamydia(tm).
| Device ID | K872148 |
| 510k Number | K872148 |
| Device Name: | VIVID CHLAMYDIA(TM) |
| Classification | Enzyme Linked Immunoabsorbent Assay, (chlamydiae Group) |
| Applicant | SERAGEN DIAGNOSTICS, INC. P.O. BOX 1210 Indianapolis, IN 46206 |
| Contact | J Sullivan |
| Correspondent | J Sullivan SERAGEN DIAGNOSTICS, INC. P.O. BOX 1210 Indianapolis, IN 46206 |
| Product Code | LJC |
| CFR Regulation Number | 866.3120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-06-04 |
| Decision Date | 1987-08-19 |