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510(k) K843619

RETIC-SET by R&D Systems, Inc. — Product Code KQC

K843619 is an FDA 510(k) premarket notification submitted by R&D Systems, Inc. for the device "RETIC-SET". The FDA issued a decision of Substantially Equivalent on October 30, 1984. The device falls under product code KQC (Stains, Hematology), a Class I device regulated under 21 CFR 864.1850. R&D Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 30, 1984
Date Received
September 14, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stains, Hematology
Device Class
Class I
Regulation Number
864.1850
Review Panel
PA
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 KQC

  • K882873 — FIELDTEX HEMATOXYLIN (July 28, 1988)
  • K852843 — GENERAL DIAGNOSTICS COAG-A-MATE XC (August 13, 1985)
  • K841848 — RETIC-SET (May 31, 1984)
  • K792550 — PONCEAU S STAIN SET (January 16, 1980)
  • K792496 — VOLU-SOL NMB RETICULOCYTE STAIN (December 31, 1979)
  • K791007 — STAT DIFF STAIN (August 3, 1979)
  • K760487 — HEMASTAIN PHOSPHATE BUFFER (August 30, 1976)
  • K760485 — HEMASTAIN FIXATIVE (August 30, 1976)

FDA data resources