K831962 is an FDA 510(k) clearance for the CHLAMYDIAZYME, ENZYME IMMUNOASSAY DETEC. 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 October 5, 1983, 110 days after receiving the submission on June 17, 1983.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 866.3120.
| 510(k) Number | K831962 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 17, 1983 |
| Decision Date | October 05, 1983 |
| Days to Decision | 110 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | LJC — Enzyme Linked Immunoabsorbent Assay, (chlamydiae Group) |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.3120 |