ZEUS SCIENTIFIC, INC. TREPONEMA PALLIDUM IGG TEST SYSTEM— 510(k) K102283
Substantially EquivalentZeus Scientific, Inc.
FDA 510(k) clearance K102283 for ZEUS SCIENTIFIC, INC. TREPONEMA PALLIDUM IGG TEST SYSTEM, Substantially Equivalent on 2011-02-10. Applicant: Zeus Scientific, Inc.. Device class: 2.
Clearance details
- Applicant
- Zeus Scientific, Inc.
- Product code
- Code LIP
- Device class
- Class 2
- Regulation
- 21 CFR 866.3830
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Branchburg, NJ, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.