K900543 is an FDA 510(k) clearance for the CHLAMYDIAZYME DIAGNOSTIC KIT. This device is classified as a Enzyme Linked Immunoabsorbent Assay, (chlamydiae Group) (Class I - General Controls, product code LJC).
Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on May 3, 1990, 87 days after receiving the submission on February 5, 1990.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3120.
| 510(k) Number | K900543 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 05, 1990 |
| Decision Date | May 03, 1990 |
| Days to Decision | 87 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | LJC — Enzyme Linked Immunoabsorbent Assay, (chlamydiae Group) |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.3120 |