K896032 is an FDA 510(k) clearance for the MODIFIED ELISA FOR CHLAMYDIA. This device is classified as a Enzyme Linked Immunoabsorbent Assay, (chlamydiae Group) (Class I - General Controls, product code LJC).
Submitted by Fairleigh Dickinson Laboratories, Inc. (Abilene, US). The FDA issued a Cleared decision on January 29, 1990, 105 days after receiving the submission on October 16, 1989.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 866.3120.
| 510(k) Number | K896032 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 16, 1989 |
| Decision Date | January 29, 1990 |
| Days to Decision | 105 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 |