TQC CALIBRATION REFERENCE FOR PLATELETS— 510(k) K770143

Name: FDA 510(k) clearance K770143
Creator: U.S. Food and Drug Administration
Published: 1978-01-30

Substantially Equivalent

Technicon Instruments Corp.

FDA 510(k) clearance K770143 for TQC CALIBRATION REFERENCE FOR PLATELETS, Substantially Equivalent on 1978-01-30. Applicant: Technicon Instruments Corp.. Device class: 2.

Clearance details

Applicant: Technicon Instruments Corp.
Product code: Code KRY
Device class: Class 2
Regulation: 21 CFR 864.8175
Advisory panel: Hematology
Date received: 1977-01-24
Decision date: 1978-01-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KRY

view all

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
K821851 — CONTROL DIAGNOSTICS PLATELET CONTROL1982-09-02

More clearances from Technicon Instruments Corp.

view all

K914511 — TECHNICON AXON(TM) SYSTEM METHODS ANYALYE HDL CHOL1991-11-27
K914888 — TECHNICON CHEM 1(TM) SYST (GEN2 SYST)1991-11-27
K914025 — TECHNICON AXON(TM) SYSTEMS, ALT(P 5-P)/AST(P 5-P)1991-11-22
K912616 — TECHNICON IMMUNO 1 TM SYSTEM ADDITIONAL ANALYTES1991-09-25
K912413 — CHEM-LINK DATA BASE MANAGER1991-07-01

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