The following data is part of a premarket notification filed by Syva Co. with the FDA for Microtrak(r) Ii Chlamydia Eia Assay.
| Device ID | K921462 |
| 510k Number | K921462 |
| Device Name: | MICROTRAK(R) II CHLAMYDIA EIA ASSAY |
| Classification | Enzyme Linked Immunoabsorbent Assay, (chlamydiae Group) |
| Applicant | SYVA CO. 3403 YERBA BUENA RD. San Jose, CA 95135 -1500 |
| Contact | Rogers, Jr. |
| Correspondent | Rogers, Jr. SYVA CO. 3403 YERBA BUENA RD. San Jose, CA 95135 -1500 |
| Product Code | LJC |
| CFR Regulation Number | 866.3120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-03-27 |
| Decision Date | 1992-09-25 |