K984123 is an FDA 510(k) clearance for the THE APTUS (AUTOMATED) APPLICATION OF THE LEGIONELLA IGG/A/M (ELISA) TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (E. This device is classified as a Reagents, Antibody, Legionella, Direct & Indirect Fluorescent (Class II - Special Controls, product code LHL).
Submitted by Zeus Scientific, Inc. (Branchburg, US). The FDA issued a Cleared decision on January 11, 1999, 54 days after receiving the submission on November 18, 1998.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3300.
| 510(k) Number | K984123 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 18, 1998 |
| Decision Date | January 11, 1999 |
| Days to Decision | 54 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Statement |
| Product Code | LHL — Reagents, Antibody, Legionella, Direct & Indirect Fluorescent |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3300 |