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510(k) K843986

STAT-TRAK PLUS LIQUID CHEMISTRY CONTROLS 1,2 & 3 by United Diagnostics, Inc. — Product Code JJY

K843986 is an FDA 510(k) premarket notification submitted by United Diagnostics, Inc. for the device "STAT-TRAK PLUS LIQUID CHEMISTRY CONTROLS 1,2 & 3". The FDA issued a decision of Substantially Equivalent on November 27, 1984. The device falls under product code JJY (Multi-Analyte Controls, All Kinds (Assayed)), 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
November 27, 1984
Date Received
October 11, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Multi-Analyte Controls, All Kinds (Assayed)
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)
  • K844018 — GAS TRAK BRAND CO-OXIMETER CONTROLS 1,2 & 3 (November 27, 1984)
  • K831389 — STAT-TRAK LIQUID ELECTROLYTE CONTROL (August 10, 1983)
  • K831813 — CO-OXIMETER CONTROL (July 28, 1983)
  • K831814 — CALIBRATION STANDARD-HEMOGLOBIN (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 JJY

  • K162530 — Multichem IA Plus (March 31, 2017)
  • K163629 — Audit MicroControls Linearity FD Tumor Markers II (March 10, 2017)
  • K163015 — Liquichek Tumor Marker Control-Level 1; Liquichek Tumor Marker Control-Level 2; (January 10, 2017)
  • K153712 — VK-3 Verification Kit, VK-4 Verification Kit, VK-R5 Verification Kit, VK-R7 Veri (January 28, 2016)
  • K150300 — Liquichek Cardiac Markers Plus Control LT (December 11, 2015)
  • K142964 — VALIDATE Anemia Calibration Verification/ Linearity Test Kit (April 30, 2015)
  • K143379 — Liquichek Maternal Serum II Control (March 13, 2015)
  • K143573 — Audit MicroControls Linearity FD Tumor Markers II (January 16, 2015)
  • K140971 — LIQUID ASSAYED CHEMISTRY CONTROL PREMIUM PLUS LEVEL 1,2 AND LEVEL 3. (December 8, 2014)
  • K142978 — Audit MicroControls Linearity LQ Special Diabetes (November 20, 2014)

FDA data resources