S-CAL HEMATOLOGY CALIBRATOR— 510(k) K862122

Name: FDA 510(k) clearance K862122
Creator: U.S. Food and Drug Administration
Published: 1987-05-20

Substantially Equivalent

Coulter Electronics, Inc.

FDA 510(k) clearance K862122 for S-CAL HEMATOLOGY CALIBRATOR, Substantially Equivalent on 1987-05-20. Applicant: Coulter Electronics, Inc.. Device class: 2.

Clearance details

Applicant: Coulter Electronics, Inc.
Product code: Code KRY
Device class: Class 2
Regulation: 21 CFR 864.8175
Advisory panel: Hematology
Date received: 1986-06-03
Decision date: 1987-05-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hialeah, FL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KRY

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K852016 — LASER PLATELETCAL/MULTIPLE1985-07-09
K843910 — COULTER MEAN PLATELET VOLUME CALIBRATOR1985-01-07
K840794 — S-CAL HEMATOLOGY CALIBRATOR1984-04-04
K821851 — CONTROL DIAGNOSTICS PLATELET CONTROL1982-09-02
K781601 — TEKNI-CAL1978-10-10

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K923530 — COULTER MULTI-Q-PREP1992-10-14
K922181 — COULTER MH0091992-08-17

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