Home / 510(k) Clearances / K970718

510(k) K970718

QUANTIKINE IVD STFR ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) by R&D Systems, Inc. — Product Code JNM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 27, 1997
Date Received
February 26, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Immunochemical, Transferrin
Device Class
Class II
Regulation Number
866.5880
Review Panel
IM
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 JNM

  • K992188 — NICHOLS ADVANTAGE CHEMILUMINESCENCE SOLUBLE TRANSFERRIN RECEPTOR IMMUNOASSAY, MO (December 6, 1999)
  • K981208 — TFR (October 21, 1998)