K921462 is an FDA 510(k) clearance for the MICROTRAK(R) II CHLAMYDIA EIA ASSAY. This device is classified as a Enzyme Linked Immunoabsorbent Assay, (chlamydiae Group) (Class I - General Controls, product code LJC).
Submitted by Syva Co. (San Jose, US). The FDA issued a Cleared decision on September 25, 1992, 182 days after receiving the submission on March 27, 1992.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3120.
| 510(k) Number | K921462 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 27, 1992 |
| Decision Date | September 25, 1992 |
| Days to Decision | 182 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | LJC — Enzyme Linked Immunoabsorbent Assay, (chlamydiae Group) |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.3120 |