The following data is part of a premarket notification filed by Diagnostic Technology, Inc. with the FDA for Chlamydia-check(tm) Direct & Culture Confir. Kit.
| Device ID | K864128 |
| 510k Number | K864128 |
| Device Name: | CHLAMYDIA-CHECK(TM) DIRECT & CULTURE CONFIR. KIT |
| Classification | Antiserum, Fluorescent, Chlamydia Trachomatis |
| Applicant | DIAGNOSTIC TECHNOLOGY, INC. 240 VANDERBILT MOTOR PKWY. Hauppauge, NY 11788 |
| Contact | Robert E Lind |
| Correspondent | Robert E Lind DIAGNOSTIC TECHNOLOGY, INC. 240 VANDERBILT MOTOR PKWY. Hauppauge, NY 11788 |
| Product Code | LJP |
| CFR Regulation Number | 866.3120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-10-21 |
| Decision Date | 1987-04-29 |