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510(k) K834505

HUMAN SERUM ELECTROLYTE CONTROL-LIQUID by Quantimetrix Corp. — Product Code JJR

K834505 is an FDA 510(k) premarket notification submitted by Quantimetrix Corp. for the device "HUMAN SERUM ELECTROLYTE CONTROL-LIQUID". The FDA issued a decision of Substantially Equivalent on April 13, 1984. The device falls under product code JJR (Electrolyte Controls (Assayed And Unassayed)), a Class I device regulated under 21 CFR 862.1660. Quantimetrix Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 13, 1984
Date Received
December 21, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrolyte Controls (Assayed And Unassayed)
Device Class
Class I
Regulation Number
862.1660
Review Panel
CH
Submission Type

Other clearances by Quantimetrix Corp.

  • K142262 — AUTION CHECK PLUS (April 10, 2015)
  • K113177 — COMPLETE D 25-OH VITAMIN D CONTROL (May 10, 2012)
  • K103744 — DROPPER A1C DIABETES CONTROL (May 12, 2011)
  • K062942 — QUANTIMETRIX NICOSURE COTININE URINE CONTROL (October 30, 2006)
  • K062751 — MODIFICATION TO QUANTIMETRIX CARDIASURE CARDIAC MARKER (October 3, 2006)
  • K060417 — MODIFICATION TO QUANTIMETRIX URINE DRUGS OF ABUSE CONTROL (March 21, 2006)
  • K032791 — GLYCOHEMOSURE HBA1C CONTROL (October 30, 2003)
  • K030826 — PRECISET DAT AMPHETAMINE (April 3, 2003)
  • K021393 — PRECISET DAT PLUS (June 13, 2002)
  • K013662 — MODIFICATION TO LIPOPRINT SYSTEM, LDL SUBFRACTIONS (March 8, 2002)

Other clearances for product code JJR

  • K990971 — EASYLYTE QUALITY CONTROL KIT, MODELS 2814, 2815, 2816 (April 27, 1999)
  • K960592 — ELECTROLYTE STANDARDS (May 13, 1996)
  • K955630 — RNA MEDICAL HEMAT CONTROL (March 1, 1996)
  • K951435 — AALTO SCIENTIFIC SWEAT CHLORIDE REFERENCE MATERIAL (May 2, 1995)
  • K943925 — SWEAT CONTROLS FOR CYSTIC FIBROSIS TESTING (October 4, 1994)
  • K934641 — I-STAT CONTROL LEVELS 1,2,3 (December 9, 1993)
  • K912513 — ELECTROLYTE CONTROL (July 19, 1991)
  • K902266 — ELECTROLYTE CONTROLS (ASSAYED AND UNASSAYED) (June 6, 1990)
  • K894576 — CIBA CORNING CERTAIN LYTE (October 30, 1989)
  • K895582 — QCLYTE PROTEIN-BASED ISE CONTROL (October 4, 1989)

FDA data resources