The following data is part of a premarket notification filed by Intl. Cytobrush, Inc. with the FDA for Chlamydia Kit, Std Kit.
| Device ID | K862322 |
| 510k Number | K862322 |
| Device Name: | CHLAMYDIA KIT, STD KIT |
| Classification | Spatula, Cervical, Cytological |
| Applicant | INTL. CYTOBRUSH, INC. P.O. BOX 7733 Hollywood, FL 33081 |
| Contact | Tse, Ph.d. |
| Correspondent | Tse, Ph.d. INTL. CYTOBRUSH, INC. P.O. BOX 7733 Hollywood, FL 33081 |
| Product Code | HHT |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-06-19 |
| Decision Date | 1986-07-07 |