AMYLASE TEST KIT— 510(k) K872023
Substantially EquivalentCiba Corning Diagnostics Corp.
FDA 510(k) clearance K872023 for AMYLASE TEST KIT, Substantially Equivalent on 1987-08-05. Applicant: Ciba Corning Diagnostics Corp.. Device class: 2.
Clearance details
- Applicant
- Ciba Corning Diagnostics Corp.
- Product code
- Code JFJ
- Device class
- Class 2
- Regulation
- 21 CFR 862.1070
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Oberlin, OH, US
Recent devices under product code JFJ
view all- K210633 — Amylase2
- K191454 — Atellica CH Amylase_2 (AMY_2)
- K182474 — alpha-AMYLASE DIRECT, alpha-AMYLASE EPS, alpha-AMYLASE PANCREATIC, BILIRUBIN DIRECT, BILIRUBIN TOTAL
- K130685 — HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGES FOR LD AND AMY
- K122858 — ELTECH CHINICAL SYSTEM AMYLASE SL ELITECH CLINICAL SYSTEMS ELICAL2 ELTECH CLINICAL SYSTEMS ELITROL I AND ELITROL II
More clearances from Ciba Corning Diagnostics Corp.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.