Submission Details
| 510(k) Number | K100728 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 15, 2010 |
| Decision Date | July 06, 2010 |
| Days to Decision | 113 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
Cleared
Traditional
ATHENA MULTI-LYTE BORRELIA VLSE-1/PEPC10 PLUS TEST SYSTEM
Jul 2010
Decision
113d
Days
Class 2
Risk
About This 510(k) Submission
K100728 is an FDA 510(k) clearance for the ATHENA MULTI-LYTE BORRELIA VLSE-1/PEPC10 PLUS TEST SYSTEM, 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 July 6, 2010, 113 days after receiving the submission on March 15, 2010. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3830.
Device Classification
| Product Code | LSR — Reagent, Borrelia Serological Reagent |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 866.3830 |
Manufacturer
Similar Devices — LSR Reagent, Borrelia Serological Reagent
All 110
K252627 · Inanovate, Inc.
· Nov 2025
K242872 · Id-Fish Technology, Inc.
· Jun 2025
K233367 · Id-Fish Technology, Inc.
· Aug 2024
K230863 · Zeus Scientific
· Jul 2023
K220016 · Viramed Biotech AG
· Aug 2022
K203289 · Gold Standard Diagnostics
· Mar 2021
More from Zeus Scientific, Inc.
View all
K201956
· DHN · Apr 2022
K190907
· LSR · Jul 2019
K191240
· LSR · Jul 2019
K191398
· LSR · Jul 2019
K113397
· LSR · Jul 2012