Home / 510(k) Clearances / K931523

510(k) K931523

QUANTIMETRIX C-CLEAR(TM) by Quantimetrix Corp. — Product Code JMA

K931523 is an FDA 510(k) premarket notification submitted by Quantimetrix Corp. for the device "QUANTIMETRIX C-CLEAR(TM)". The FDA issued a decision of Substantially Equivalent on June 25, 1993. The device falls under product code JMA (Acid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric)), a Class I device regulated under 21 CFR 862.1095. Quantimetrix Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 25, 1993
Date Received
March 26, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Acid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric)
Device Class
Class I
Regulation Number
862.1095
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 JMA

  • K830978 — HELENA BIOSTRIP A (May 13, 1983)
  • K822709 — URITEST 9, INLAB REAGENT STRIPS URINALY (January 28, 1983)

FDA data resources