Devices · CELLAVISION AB

DIFFMASTER OCTAVIA AUTOMATIC HEMATOLOGY ANALYZER

CELLAVISION AB is listed for DIFFMASTER OCTAVIA AUTOMATIC HEMATOLOGY ANALYZER (K003301). The FDA list gives March 15, 2001 as the date of the final decision. The lead panel is Hematology, and the database link on the FDA list is the 510(k) pathway. The primary product code on the FDA list is JOY. openFDA did not return a classification record for that code in this copy of the data. openFDA records this submission’s decision description as “Substantially Equivalent.” This paragraph is assembled only from those public fields. It is not an FDA review, not a determination of safety or effectiveness, and not medical advice. Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K003301

Official FDA database record

Date of final decision

March 15, 2001

Company on the FDA list

CELLAVISION AB

Lead panel

Hematology

Primary product code

JOY

openFDA device name for the code

Device, Automated Cell-Locating

Device class

2

Regulation number

864.5260

openFDA decision description

Substantially Equivalent

openFDA decision code

SESE

Statement or summary label

Summary