The following data is part of a premarket notification filed by Syncor Intl. Corp. with the FDA for Syncortech Chlamydia Direct Speciman Kit.
Device ID | K851033 |
510k Number | K851033 |
Device Name: | SYNCORTECH CHLAMYDIA DIRECT SPECIMAN KIT |
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 | 1985-03-12 |
Decision Date | 1985-06-21 |