The following data is part of a premarket notification filed by California Integrated Diagnostics, Inc. with the FDA for Modified Chlamydia Direct Specimen Test Kit.
| Device ID | K871278 |
| 510k Number | K871278 |
| Device Name: | MODIFIED CHLAMYDIA DIRECT SPECIMEN TEST KIT |
| Classification | Antiserum, Fluorescent, Chlamydia Trachomatis |
| Applicant | CALIFORNIA INTEGRATED DIAGNOSTICS, INC. 1440 FOURTH ST. Berkeley, CA 94710 |
| Contact | Mark S Tanaka |
| Correspondent | Mark S Tanaka CALIFORNIA INTEGRATED DIAGNOSTICS, INC. 1440 FOURTH ST. Berkeley, CA 94710 |
| Product Code | LJP |
| CFR Regulation Number | 866.3120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-03-31 |
| Decision Date | 1987-04-08 |