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510(k) K840794

S-CAL HEMATOLOGY CALIBRATOR by Coulter Electronics, Inc. — Product Code KRY

K840794 is an FDA 510(k) premarket notification submitted by Coulter Electronics, Inc. for the device "S-CAL HEMATOLOGY CALIBRATOR". The FDA issued a decision of Substantially Equivalent on April 4, 1984. The device falls under product code KRY (Calibrator For Platelet Counting), a Class II device regulated under 21 CFR 864.8175. Coulter Electronics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 4, 1984
Date Received
February 23, 1984
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 by Coulter Electronics, Inc.

  • K923951 — CD8 CYTOSPHERES KIT (April 25, 1994)
  • K930119 — COULTER RETIC-C CELL CONTROL (April 5, 1993)
  • K921279 — CD4 CYTOSPHERES KIT (December 29, 1992)
  • K923530 — COULTER MULTI-Q-PREP (October 14, 1992)
  • K922181 — COULTER MH009 (August 17, 1992)
  • K922704 — COULTER MAXM W/ AUTOLOADER (July 27, 1992)
  • K921567 — COULTER MH017 (July 6, 1992)
  • K912133 — PX COULTER(R) CELL CONTROL (July 17, 1991)
  • K911385 — COULTER(R) MH010 (June 17, 1991)
  • K905771 — COULTER DART AST (GOT) REAGENT (February 26, 1991)

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)
  • K821851 — CONTROL DIAGNOSTICS PLATELET CONTROL (September 2, 1982)
  • K781601 — TEKNI-CAL (October 10, 1978)
  • K781133 — PC-CALIBRATOR (August 14, 1978)
  • K770143 — TQC CALIBRATION REFERENCE FOR PLATELETS (January 30, 1978)

FDA data resources