CALIBRATION KIT— 510(k) K882220

Substantially Equivalent

King Diagnostics, Inc.

FDA 510(k) clearance K882220 for CALIBRATION KIT, Substantially Equivalent on 1988-08-02. Applicant: King Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: King Diagnostics, Inc.
Product code: Code JIW
Device class: Class 2
Regulation: 21 CFR 862.1150
Advisory panel: Clinical Chemistry
Date received: 1988-05-26
Decision date: 1988-08-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

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K923129 — KING DIAGNOSTICS GLUCOSE (HK) REAGENT1992-11-02

Data sourced from openFDA. This site is unofficial and independent of the FDA.