Submission Details
| 510(k) Number | K102283 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 12, 2010 |
| Decision Date | February 10, 2011 |
| Days to Decision | 182 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
Cleared
Traditional
ZEUS SCIENTIFIC, INC. TREPONEMA PALLIDUM IGG TEST SYSTEM
Feb 2011
Decision
182d
Days
Class 2
Risk
About This 510(k) Submission
K102283 is an FDA 510(k) clearance for the ZEUS SCIENTIFIC, INC. TREPONEMA PALLIDUM IGG TEST SYSTEM, a Enzyme Linked Immunoabsorption Assay, Treponema Pallidum (Class II — Special Controls, product code LIP), submitted by Zeus Scientific, Inc. (Branchburg, US). The FDA issued a Cleared decision on February 10, 2011, 182 days after receiving the submission on August 12, 2010. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3830.
Device Classification
| Product Code | LIP — Enzyme Linked Immunoabsorption Assay, Treponema Pallidum |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 866.3830 |
Manufacturer
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