K984138 is an FDA 510(k) clearance for the APTUS (AUTOMATED) APPLICATION FOR THE B. BURGDORFERI ANTIBODY ELISA TEST SYSTEM. This device is classified as a Reagent, Borrelia Serological Reagent (Class II - Special Controls, product code LSR).
Submitted by Zeus Scientific, Inc. (Branchburg, US). The FDA issued a Cleared decision on March 23, 1999, 125 days after receiving the submission on November 18, 1998.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3830.
| 510(k) Number | K984138 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 18, 1998 |
| Decision Date | March 23, 1999 |
| Days to Decision | 125 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Statement |
| Product Code | LSR — Reagent, Borrelia Serological Reagent |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3830 |