HGB-CAL SET/MULTIPLE— 510(k) K893984

Substantially Equivalent

R&D Systems, Inc.

FDA 510(k) clearance K893984 for HGB-CAL SET/MULTIPLE, Substantially Equivalent on 1989-08-15. Applicant: R&D Systems, Inc.. Device class: 2.

Clearance details

Applicant: R&D Systems, Inc.
Product code: Code KRZ
Device class: Class 2
Regulation: 21 CFR 864.8165
Advisory panel: Hematology
Date received: 1989-06-05
Decision date: 1989-08-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minneapolis, MN, 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.