CONTROL DIAGNOSTICS PLATELET CONTROL— 510(k) K821851

Name: FDA 510(k) clearance K821851
Creator: U.S. Food and Drug Administration
Published: 1982-09-02

Substantially Equivalent

Immunogenetics

FDA 510(k) clearance K821851 for CONTROL DIAGNOSTICS PLATELET CONTROL, Substantially Equivalent on 1982-09-02. Applicant: Immunogenetics. Device class: 2.

Clearance details

Applicant: Immunogenetics
Product code: Code KRY
Device class: Class 2
Regulation: 21 CFR 864.8175
Advisory panel: Hematology
Date received: 1982-06-23
Decision date: 1982-09-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Recent devices under product code KRY

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K862122 — S-CAL HEMATOLOGY CALIBRATOR1987-05-20
K852016 — LASER PLATELETCAL/MULTIPLE1985-07-09
K843910 — COULTER MEAN PLATELET VOLUME CALIBRATOR1985-01-07
K840794 — S-CAL HEMATOLOGY CALIBRATOR1984-04-04
K781601 — TEKNI-CAL1978-10-10

Data sourced from openFDA. This site is unofficial and independent of the FDA.