DeviceClearance

IQ 200 SYSTEM— 510(k) K022774

Substantially Equivalent

Intl. Remote Imaging Systems

FDA 510(k) clearance K022774 for IQ 200 SYSTEM, Substantially Equivalent on 2002-10-21. Applicant: Intl. Remote Imaging Systems. Device class: 2.

Clearance details

Applicant
Intl. Remote Imaging Systems
Product code
Code LKM
Device class
Class 2
Regulation
21 CFR 864.5200
Advisory panel
Hematology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Chatsworth, CA, US
Download summary PDFView on FDA.gov ↗

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Recalls naming K022774

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K022774.

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