Submission Details
| 510(k) Number | K113397 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 17, 2011 |
| Decision Date | July 26, 2012 |
| Days to Decision | 252 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Statement |
Cleared
Traditional
ZEUS ELISA BORRELIA VLSE-1/PEPC10 IGG/IGM TEST SYSTEM
Jul 2012
Decision
252d
Days
Class 2
Risk
About This 510(k) Submission
K113397 is an FDA 510(k) clearance for the ZEUS ELISA BORRELIA VLSE-1/PEPC10 IGG/IGM 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 26, 2012, 252 days after receiving the submission on November 17, 2011. 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
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