R & D 4K RETIC— 510(k) K010470

Substantially Equivalent

R&D Systems, Inc.

FDA 510(k) clearance K010470 for R & D 4K RETIC, Substantially Equivalent on 2001-05-11. Applicant: R&D Systems, Inc.. Device class: 2.

Clearance details

Applicant: R&D Systems, Inc.
Product code: Code JPK
Device class: Class 2
Regulation: 21 CFR 864.8625
Advisory panel: Hematology
Date received: 2001-02-20
Decision date: 2001-05-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minneapolis, MN, US

Download summary PDF View on FDA.gov ↗

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