The following data is part of a premarket notification filed by Boots-celltech Diagnostics, Inc. with the FDA for Ideia(tm) Chlamydia Specimen Collection Kit.
| Device ID | K864998 |
| 510k Number | K864998 |
| Device Name: | IDEIA(TM) CHLAMYDIA SPECIMEN COLLECTION KIT |
| Classification | Culture Media, Non-propagating Transport |
| Applicant | BOOTS-CELLTECH DIAGNOSTICS, INC. 240 BATH ROAD SLOUGH SL1 4ET Berkshire, England, GB |
| Contact | John G Simpson |
| Correspondent | John G Simpson BOOTS-CELLTECH DIAGNOSTICS, INC. 240 BATH ROAD SLOUGH SL1 4ET Berkshire, England, GB |
| Product Code | JSM |
| CFR Regulation Number | 866.2390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-12-22 |
| Decision Date | 1987-04-20 |