ACLAIMS-IS— 510(k) K912085

Substantially Equivalent

W-Technology

FDA 510(k) clearance K912085 for ACLAIMS-IS, Substantially Equivalent on 1991-10-31. Applicant: W-Technology. Device class: 2.

Clearance details

Applicant: W-Technology
Product code: Code LNJ
Device class: Class 2
Regulation: 21 CFR 864.5260
Advisory panel: Hematology
Date received: 1991-05-13
Decision date: 1991-10-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carmichael, CA, US

Download summary PDF View on FDA.gov ↗

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