The following data is part of a premarket notification filed by California Integrated Diagnostics, Inc. with the FDA for Trichomonas Direct Enzyme Immunoassay.
| Device ID | K874259 |
| 510k Number | K874259 |
| Device Name: | TRICHOMONAS DIRECT ENZYME IMMUNOASSAY |
| Classification | Kit, Screening, Trichomonas |
| Applicant | CALIFORNIA INTEGRATED DIAGNOSTICS, INC. 1440 FOURTH ST. Berkeley, CA 94710 |
| Contact | Gary J Casaretto |
| Correspondent | Gary J Casaretto 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 | 1987-10-20 |
| Decision Date | 1987-12-07 |