CRC(CYANMETHEMOGLOBIN REAGENT CONCENT— 510(k) K802268

Name: FDA 510(k) clearance K802268
Creator: U.S. Food and Drug Administration
Published: 1980-12-31

Substantially Equivalent

R&D Systems, Inc.

FDA 510(k) clearance K802268 for CRC(CYANMETHEMOGLOBIN REAGENT CONCENT, Substantially Equivalent on 1980-12-31. Applicant: R&D Systems, Inc.. Device class: 2.

Clearance details

Applicant: R&D Systems, Inc.
Product code: Code KHG
Device class: Class 2
Regulation: 21 CFR 864.7500
Advisory panel: Hematology
Date received: 1980-09-16
Decision date: 1980-12-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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