K864842 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 April 29, 1987, 140 days after receiving the submission on December 10, 1986.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3120.
| 510(k) Number | K864842 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 10, 1986 |
| Decision Date | April 29, 1987 |
| Days to Decision | 140 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 |