The following data is part of a premarket notification filed by Boots-celltech Diagnostics, Inc. with the FDA for Modified (directions For Use) For Ideia(tm) Test.
| Device ID | K872056 |
| 510k Number | K872056 |
| Device Name: | MODIFIED (DIRECTIONS FOR USE) FOR IDEIA(TM) TEST |
| Classification | Enzyme Linked Immunoabsorbent Assay, (chlamydiae Group) |
| Applicant | BOOTS-CELLTECH DIAGNOSTICS, INC. 240 BATH ROAD SLOUGH SL1 4ET Berkshire, England, GB |
| Contact | Abbott, Phd |
| Correspondent | Abbott, Phd BOOTS-CELLTECH DIAGNOSTICS, INC. 240 BATH ROAD SLOUGH SL1 4ET Berkshire, England, GB |
| Product Code | LJC |
| CFR Regulation Number | 866.3120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-05-28 |
| Decision Date | 1987-06-15 |