IS EBV-EA-D IGG ELISA TEST SYSTEM— 510(k) K981831
Substantially EquivalentDiamedix Corp.
FDA 510(k) clearance K981831 for IS EBV-EA-D IGG ELISA TEST SYSTEM, Substantially Equivalent on 1999-02-16. Applicant: Diamedix Corp.. Device class: 1.
Clearance details
- Applicant
- Diamedix Corp.
- Product code
- Code GNP
- Device class
- Class 1
- Regulation
- 21 CFR 866.3235
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Columbia, MD, US
Recent devices under product code GNP
view allMore clearances from Diamedix Corp.
view allRecalls naming K981831
K-number listed on FDA's recall record- Z-2574-2018 — Diamedix Is-EBV-EA-D IgG Enzyme Immunoassay Test Kit for In Vitro Diagnostic Use Catalog No. 720-640
- Z-1687-2016 — Diamedix Is-EBV-EA-D IgG Test Kit Diamedix Is-Mumps IgG Test Kit is an EIA procedure intended for the qualitative and semi-quantitative detection of Mumps IgG antibodies as an aid in the diagnosis of Mumps infection.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K981831.
Data sourced from openFDA. This site is unofficial and independent of the FDA.