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510(k) K882490

HYCEL QUICK-LYSING HEMOGLOBIN REAGENT by R&D Systems, Inc. — Product Code GIF

K882490 is an FDA 510(k) premarket notification submitted by R&D Systems, Inc. for the device "HYCEL QUICK-LYSING HEMOGLOBIN REAGENT". The FDA issued a decision of Substantially Equivalent on July 25, 1988. The device falls under product code GIF (Diluent, Blood Cell), a Class I device regulated under 21 CFR 864.8200. R&D Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 25, 1988
Date Received
June 16, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Diluent, Blood Cell
Device Class
Class I
Regulation Number
864.8200
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 GIF

  • K883990 — KVM ISOTONIC DILUENT (October 12, 1988)
  • K883989 — KVM ISOTONIC FLUSH SOLUTION (October 12, 1988)
  • K882267 — SYSMEX QUICKLYSER-II (QLS-200A) (July 12, 1988)
  • K881130 — CELL-DYN ISOTONIC DILUENT (March 31, 1988)
  • K873347 — CELL-DYN DIFF. SCREEN ISOTONIC DILUENT (September 9, 1987)
  • K851843 — OSMOCEL 3 (July 30, 1985)
  • K851280 — DASS PACK (July 5, 1985)
  • K851320 — SDI PREPAX DILUKIT M. (July 5, 1985)
  • K850239 — SYSMEX HEMATOLOGICAL WHOLE BLOOD DILUTING REAGENT- (April 1, 1985)
  • K850095 — LASER-DIL (March 29, 1985)

FDA data resources