The following data is part of a premarket notification filed by Difco Laboratories, Inc. with the FDA for Difco Chlamydia Direct Detection System.
| Device ID | K862320 |
| 510k Number | K862320 |
| Device Name: | DIFCO CHLAMYDIA DIRECT DETECTION SYSTEM |
| Classification | Antiserum, Fluorescent, Chlamydia Trachomatis |
| Applicant | DIFCO LABORATORIES, INC. 1180 ELLSWORTH RD. Ann Arbor, MI 48104 |
| Contact | Walter S Fisher |
| Correspondent | Walter S Fisher DIFCO LABORATORIES, INC. 1180 ELLSWORTH RD. Ann Arbor, MI 48104 |
| Product Code | LJP |
| CFR Regulation Number | 866.3120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-06-18 |
| Decision Date | 1986-08-19 |