The following data is part of a premarket notification filed by Difco Laboratories, Inc. with the FDA for Cellmatics Shlamydia Detection System.
| Device ID | K893669 |
| 510k Number | K893669 |
| Device Name: | CELLMATICS SHLAMYDIA DETECTION SYSTEM |
| Classification | Antisera, Immunoperoxidase, Chlamydia Spp. |
| Applicant | DIFCO LABORATORIES, INC. P.O. BOX 331058 Detroit, MI 48232 -7058 |
| Contact | Robert |
| Correspondent | Robert DIFCO LABORATORIES, INC. P.O. BOX 331058 Detroit, MI 48232 -7058 |
| Product Code | LKH |
| CFR Regulation Number | 866.3120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-05-15 |
| Decision Date | 1989-06-23 |