RED BLOOD CELL COUNT & HEMATOCRIT CNTL— 510(k) K801267

Name: FDA 510(k) clearance K801267
Creator: U.S. Food and Drug Administration
Published: 1980-07-14

Substantially Equivalent

Bioscientific

FDA 510(k) clearance K801267 for RED BLOOD CELL COUNT & HEMATOCRIT CNTL, Substantially Equivalent on 1980-07-14. Applicant: Bioscientific. Device class: 2.

Clearance details

Applicant: Bioscientific
Product code: Code JPK
Device class: Class 2
Regulation: 21 CFR 864.8625
Advisory panel: Hematology
Date received: 1980-05-28
Decision date: 1980-07-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, 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.