Product code KRY— Hematology

S-CAL HEMATOLOGY CALIBRATOR

Classification name: Calibrator For Platelet Counting
Device class: Class 2
Regulation: 21 CFR 864.8175
Advisory panel: Hematology
Total cleared: 8
First cleared: 1978-01-30
Most recent: 1987-05-20

Market context for product code KRY

FDA has cleared 8 devices under product code KRY between 1978 and 1987, filed by 5 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

19871 clearance
19852 clearances
19841 clearance
19821 clearance
19783 clearances

Top applicants under product code KRY

Recent clearances under product code KRY

K862122 — S-CAL HEMATOLOGY CALIBRATORCoulter Electronics, Inc.·1987-05-20
K852016 — LASER PLATELETCAL/MULTIPLER&D Systems, Inc.·1985-07-09
K843910 — COULTER MEAN PLATELET VOLUME CALIBRATORCoulter Electronics, Inc.·1985-01-07
K840794 — S-CAL HEMATOLOGY CALIBRATORCoulter Electronics, Inc.·1984-04-04
K821851 — CONTROL DIAGNOSTICS PLATELET CONTROLImmunogenetics·1982-09-02
K781601 — TEKNI-CALStreck Laboratories, Inc.·1978-10-10
K781133 — PC-CALIBRATORStreck Laboratories, Inc.·1978-08-14
K770143 — TQC CALIBRATION REFERENCE FOR PLATELETSTechnicon Instruments Corp.·1978-01-30

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