The following data is part of a premarket notification filed by California Integrated Diagnostics, Inc. with the FDA for Modified Trichomonas Direct Specimen Test Kit.
| Device ID | K871279 |
| 510k Number | K871279 |
| Device Name: | MODIFIED TRICHOMONAS DIRECT SPECIMEN TEST KIT |
| Classification | Kit, Screening, Trichomonas |
| 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 | JWZ |
| CFR Regulation Number | 866.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-03-31 |
| Decision Date | 1987-04-08 |