K915281 is an FDA 510(k) clearance for the SEROLISA CHLAMYDIA IGG TEST KIT. This device is classified as a Enzyme Linked Immunoabsorbent Assay, (chlamydiae Group) (Class I - General Controls, product code LJC).
Submitted by Savyon Diagnostics , Ltd. (Sheva, Israel, IL). The FDA issued a Cleared decision on March 23, 1992, 119 days after receiving the submission on November 25, 1991.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3120.
| 510(k) Number | K915281 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 25, 1991 |
| Decision Date | March 23, 1992 |
| Days to Decision | 119 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 |