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 |