The following data is part of a premarket notification filed by Syncor Intl. Corp. with the FDA for Syncor Trich Direct Immunofluorescence Assay.
| Device ID | K852665 |
| 510k Number | K852665 |
| Device Name: | SYNCOR TRICH DIRECT IMMUNOFLUORESCENCE ASSAY |
| Classification | Kit, Screening, Trichomonas |
| Applicant | SYNCOR INTL. CORP. 1440 FOURTH ST. Berkeley, CA 94710 |
| Contact | Terry D Smith |
| Correspondent | Terry D Smith SYNCOR INTL. CORP. 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 | 1985-06-24 |
| Decision Date | 1985-08-13 |