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510(k) K831389

STAT-TRAK LIQUID ELECTROLYTE CONTROL by United Diagnostics, Inc. — Product Code JJR

K831389 is an FDA 510(k) premarket notification submitted by United Diagnostics, Inc. for the device "STAT-TRAK LIQUID ELECTROLYTE CONTROL". The FDA issued a decision of Substantially Equivalent on August 10, 1983. The device falls under product code JJR (Electrolyte Controls (Assayed And Unassayed)), a Class I device regulated under 21 CFR 862.1660. United Diagnostics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 10, 1983
Date Received
April 29, 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 United Diagnostics, Inc.

  • K884977 — GAS TRAK PLUS (January 27, 1989)
  • K862278 — GAS-TRAK (August 4, 1986)
  • K843986 — STAT-TRAK PLUS LIQUID CHEMISTRY CONTROLS 1,2 & 3 (November 27, 1984)
  • K844018 — GAS TRAK BRAND CO-OXIMETER CONTROLS 1,2 & 3 (November 27, 1984)
  • K831814 — CALIBRATION STANDARD-HEMOGLOBIN (July 28, 1983)
  • K831813 — CO-OXIMETER CONTROL (July 28, 1983)
  • K831075 — BLOOD GAS & FLAME PHOTOMETER INSTRU- (June 22, 1983)
  • K820705 — GAS-TRAK 2 SYNTHETIC BLOOD GAS CONTROL (April 1, 1982)
  • K813517 — BLOOD GAS ANALYSIS, STANDARDS CONTROLS (December 31, 1981)
  • K810618 — AMPULED FLAME PHOTOMETER STANDARDS (March 31, 1981)

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