The following data is part of a premarket notification filed by Eastman Kodak Company with the FDA for Add'l Uses For The Kodak Surecell Chlamydia Kit.
| Device ID | K900402 |
| 510k Number | K900402 |
| Device Name: | ADD'L USES FOR THE KODAK SURECELL CHLAMYDIA KIT |
| Classification | Enzyme Linked Immunoabsorbent Assay, (chlamydiae Group) |
| Applicant | EASTMAN KODAK COMPANY 343 STATE ST. Rochester, NY 14650 |
| Contact | Norman H Geil |
| Correspondent | Norman H Geil EASTMAN KODAK COMPANY 343 STATE ST. Rochester, NY 14650 |
| Product Code | LJC |
| CFR Regulation Number | 866.3120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-01-29 |
| Decision Date | 1990-03-08 |