The following data is part of a premarket notification filed by Syva Co. with the FDA for Syva Microtrak Chlamlydia Eia, Modification.
| Device ID | K905179 |
| 510k Number | K905179 |
| Device Name: | SYVA MICROTRAK CHLAMLYDIA EIA, MODIFICATION |
| Classification | Enzyme Linked Immunoabsorbent Assay, (chlamydiae Group) |
| Applicant | SYVA CO. 900 ARASTRADERO RD. P.O. BOX 10058 Palo Alto, CA 94303 |
| Contact | Paul Rogers |
| Correspondent | Paul Rogers SYVA CO. 900 ARASTRADERO RD. P.O. BOX 10058 Palo Alto, CA 94303 |
| Product Code | LJC |
| CFR Regulation Number | 866.3120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-11-19 |
| Decision Date | 1991-03-12 |