The following data is part of a premarket notification filed by Abbott Laboratories with the FDA for Abbott Testpack Chlamydia.
| Device ID | K880783 |
| 510k Number | K880783 |
| Device Name: | ABBOTT TESTPACK CHLAMYDIA |
| Classification | Enzyme Linked Immunoabsorbent Assay, (chlamydiae Group) |
| Applicant | ABBOTT LABORATORIES ONE ABBOTT PARK RD. Abbott Park, IL 60064 -3500 |
| Contact | Jean Frydman |
| Correspondent | Jean Frydman ABBOTT LABORATORIES ONE ABBOTT PARK RD. Abbott Park, IL 60064 -3500 |
| Product Code | LJC |
| CFR Regulation Number | 866.3120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-02-26 |
| Decision Date | 1988-07-25 |