The following data is part of a premarket notification filed by Syncor Intl. Corp. with the FDA for Syncor Tech Chlamydia Tissue Culture Test.
| Device ID | K844582 |
| 510k Number | K844582 |
| Device Name: | SYNCOR TECH CHLAMYDIA TISSUE CULTURE TEST |
| Classification | Antiserum, Fluorescent, Chlamydia Trachomatis |
| Applicant | SYNCOR INTL. CORP. 12847 ARROYO ST. Sylmar, CA 91342 |
| Contact | Eleanor V Chiu |
| Correspondent | Eleanor V Chiu SYNCOR INTL. CORP. 12847 ARROYO ST. Sylmar, CA 91342 |
| Product Code | LJP |
| CFR Regulation Number | 866.3120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-11-23 |
| Decision Date | 1985-01-16 |