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510(k) K852016

LASER PLATELETCAL/MULTIPLE by R&D Systems, Inc. — Product Code KRY

K852016 is an FDA 510(k) premarket notification submitted by R&D Systems, Inc. for the device "LASER PLATELETCAL/MULTIPLE". The FDA issued a decision of Substantially Equivalent on July 9, 1985. The device falls under product code KRY (Calibrator For Platelet Counting), a Class II device regulated under 21 CFR 864.8175. R&D Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 9, 1985
Date Received
May 9, 1985
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 R&D Systems, Inc.

  • K160606 — BC-5D Hematology Control (September 1, 2016)
  • K130962 — R&D 5D RETIC HEMATOLOGY CONTROL (July 24, 2013)
  • K101578 — R&D SYSTEMS BODY FLUID-I HEMATOLOGY CONTROL (April 28, 2011)
  • K100050 — R & D SYSTEMS XERET HEMATOLOGY CONTROL (January 29, 2010)
  • K091433 — R&D SYSTEMS TETIC-I PLUS HEMOTOLOGY CONTROL (October 28, 2009)
  • K073178 — HCT EXTENDED HEMATOLOGY CONTROL, MODEL HCT004 (December 27, 2007)
  • K072846 — CSF AUTOMATED CONTROL, MODELS CSF001, CSF003 (November 26, 2007)
  • K072268 — HC WBC HEMATOLOGY CONTROL, MODEL: WBC00S (November 20, 2007)
  • K072096 — CBC-5D PLUS RETICS HEMATOLOGY CONTROL, MODELS: 5DR03, 5DR04 (August 20, 2007)
  • K070334 — R&D SICKLE QC CONTROL (March 29, 2007)

Other clearances for product code KRY

  • K862122 — S-CAL HEMATOLOGY CALIBRATOR (May 20, 1987)
  • K843910 — COULTER MEAN PLATELET VOLUME CALIBRATOR (January 7, 1985)
  • K840794 — S-CAL HEMATOLOGY CALIBRATOR (April 4, 1984)
  • 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