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510(k) K821851

CONTROL DIAGNOSTICS PLATELET CONTROL by Immunogenetics — Product Code KRY

K821851 is an FDA 510(k) premarket notification submitted by Immunogenetics for the device "CONTROL DIAGNOSTICS PLATELET CONTROL". The FDA issued a decision of Substantially Equivalent on September 2, 1982. The device falls under product code KRY (Calibrator For Platelet Counting), a Class II device regulated under 21 CFR 864.8175.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 2, 1982
Date Received
June 23, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calibrator For Platelet Counting
Device Class
Class II
Regulation Number
864.8175
Review Panel
HE
Submission Type

Other clearances for product code KRY

  • K862122 — S-CAL HEMATOLOGY CALIBRATOR (May 20, 1987)
  • K852016 — LASER PLATELETCAL/MULTIPLE (July 9, 1985)
  • K843910 — COULTER MEAN PLATELET VOLUME CALIBRATOR (January 7, 1985)
  • K840794 — S-CAL HEMATOLOGY CALIBRATOR (April 4, 1984)
  • K781601 — TEKNI-CAL (October 10, 1978)
  • K781133 — PC-CALIBRATOR (August 14, 1978)
  • K770143 — TQC CALIBRATION REFERENCE FOR PLATELETS (January 30, 1978)

FDA data resources