The following data is part of a premarket notification filed by Boots-celltech Diagnostics, Inc. with the FDA for Modified Ideia Chlamydia Test.
| Device ID | K880799 |
| 510k Number | K880799 |
| Device Name: | MODIFIED IDEIA CHLAMYDIA TEST |
| Classification | Enzyme Linked Immunoabsorbent Assay, (chlamydiae Group) |
| Applicant | BOOTS-CELLTECH DIAGNOSTICS, INC. BUILDING 300, SUITE 200 I-94 AT HIGHWAY 22 Lincolnshire, IL 60015 |
| Contact | S Wells |
| Correspondent | S Wells BOOTS-CELLTECH DIAGNOSTICS, INC. BUILDING 300, SUITE 200 I-94 AT HIGHWAY 22 Lincolnshire, IL 60015 |
| Product Code | LJC |
| CFR Regulation Number | 866.3120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-02-29 |
| Decision Date | 1988-12-08 |