Zeus IFA ANA HEp-2 Test System, Zeus dIFine— 510(k) K201956
Substantially EquivalentZeus Scientific, Inc.
FDA 510(k) clearance K201956 for Zeus IFA ANA HEp-2 Test System, Zeus dIFine, Substantially Equivalent on 2022-04-29. Applicant: Zeus Scientific, Inc.. Device class: 2.
Clearance details
- Applicant
- Zeus Scientific, Inc.
- Product code
- Code DHN
- Device class
- Class 2
- Regulation
- 21 CFR 866.5100
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Raritan, NJ, US
Recent devices under product code DHN
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- K191398 — ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgG Test System
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Data sourced from openFDA. This site is unofficial and independent of the FDA.