The following data is part of a premarket notification filed by Syva Co. with the FDA for Microtrak Chlamydia Trachomatis Direct Speci. Test.
Device ID | K864888 |
510k Number | K864888 |
Device Name: | MICROTRAK CHLAMYDIA TRACHOMATIS DIRECT SPECI. TEST |
Classification | Antiserum, Fluorescent, Chlamydia Trachomatis |
Applicant | SYVA CO. 900 ARASTRADERO RD. P.O. BOX 10058 Palo Alto, CA 94303 |
Contact | Eleanor V Chiu |
Correspondent | Eleanor V Chiu SYVA CO. 900 ARASTRADERO RD. P.O. BOX 10058 Palo Alto, CA 94303 |
Product Code | LJP |
CFR Regulation Number | 866.3120 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-12-12 |
Decision Date | 1987-02-25 |