EASYRA ALB REAGENT AND EASYRA ALP REAGENT, MODEL 10218/10214, EASYRA AST REAGENT, MODEL 10206, EASYRA CO2 REAGENT— 510(k) K080874
Substantially EquivalentMedica Corp.
FDA 510(k) clearance K080874 for EASYRA ALB REAGENT AND EASYRA ALP REAGENT, MODEL 10218/10214, EASYRA AST REAGENT, MODEL 10206, EASYRA CO2 REAGENT, Substantially Equivalent on 2009-02-20. Applicant: Medica Corp.. Device class: 2.
Clearance details
- Applicant
- Medica Corp.
- Product code
- Code CIX
- Device class
- Class 2
- Regulation
- 21 CFR 862.1035
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bedford, MA, US
Recent devices under product code CIX
view all- K251157 — Core Metabolic
- K203248 — Albumin BCG2
- K200898 — Medicon Hellas Albumin, Medicon Hellas Calcium, Medicon Hellas Creatinine, Medicon Hellas Urea Nitrogen, Medicon Hellas Glucose, Medicon Hellas Total Bilirubin, Medicon Hellas Direct Bilirubin
- K191316 — VITROS XT Chemistry Products ALB-TP Slides
- K170901 — ALBUMIN, ALKALINE PHOSPHATASE (ALP)-AMP, GLUCOSE-HEXOKINASE, BA400
More clearances from Medica Corp.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.