QUANTIMETRIC PLUS IGA REAGENT KIT— 510(k) K855009
Substantially EquivalentKallestad Laboratories, Inc.
FDA 510(k) clearance K855009 for QUANTIMETRIC PLUS IGA REAGENT KIT, Substantially Equivalent on 1986-02-26. Applicant: Kallestad Laboratories, Inc.. Device class: 2.
Clearance details
- Applicant
- Kallestad Laboratories, Inc.
- Product code
- Code CZP
- Device class
- Class 2
- Regulation
- 21 CFR 866.5510
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Chaska, MN, US
Recent devices under product code CZP
view all- K193525 — Yumizen C1200 Immunoglobulin A, Yumizen C1200 Immunoglobulin G, Yumizen C1200 Immunoglobulin M
- K060130 — IMMAGE SYSTEMS LOW CONCENTRATION IMMUNOGLOBULIN A REAGENT
- K040435 — ROCHE DIAGNOSTICS TINA-QUANT IGA GEN.2
- K024038 — N LATEX IGA
- K993927 — WAKO IGA II-HA, IMMUNOGLOBULIN CALIBRATOR SET, IMMUNOGLOBULIN STANDRAD
More clearances from Kallestad Laboratories, Inc.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.