TEST, (IVDP) SMOOTHMUSCLE ANTIBODY— 510(k) K760156
Substantially EquivalentZeus Scientific, Inc.
FDA 510(k) clearance K760156 for TEST, (IVDP) SMOOTHMUSCLE ANTIBODY, Substantially Equivalent on 1976-07-20. Applicant: Zeus Scientific, Inc.. Device class: 2.
Clearance details
- Applicant
- Zeus Scientific, Inc.
- Product code
- Code DBE
- Device class
- Class 2
- Regulation
- 21 CFR 866.5120
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
Recent devices under product code DBE
view allMore clearances from Zeus Scientific, Inc.
view all- K201956 — Zeus IFA ANA HEp-2 Test System, Zeus dIFine
- K190907 — ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgG/IgM Test System
- K191240 — ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgM Test System
- K191398 — ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgG Test System
- K113397 — ZEUS ELISA BORRELIA VLSE-1/PEPC10 IGG/IGM TEST SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.