ZEUA MYCOPLASMA— 510(k) K944417
Substantially EquivalentZeus Scientific, Inc.
FDA 510(k) clearance K944417 for ZEUA MYCOPLASMA, Substantially Equivalent on 1995-08-01. Applicant: Zeus Scientific, Inc.. Device class: 1.
Clearance details
- Applicant
- Zeus Scientific, Inc.
- Product code
- Code GRZ
- Device class
- Class 1
- Regulation
- 21 CFR 866.3375
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Raritan, NJ, US
Recent devices under product code GRZ
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.