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510(k) K121468

EUROTROL GAS-ISE METABOLITES by Eurotrol B.V. — Product Code JJY

K121468 is an FDA 510(k) premarket notification submitted by Eurotrol B.V. for the device "EUROTROL GAS-ISE METABOLITES". The FDA issued a decision of Substantially Equivalent on June 22, 2012. The device falls under product code JJY (Multi-Analyte Controls, All Kinds (Assayed)), a Class I device regulated under 21 CFR 862.1660. Eurotrol B.V. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 22, 2012
Date Received
May 17, 2012
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 Eurotrol B.V.

  • K192842 — HemoTrol Duo Low, HemoTrol Duo Normal, HemoTrol Duo High (November 15, 2019)
  • K182744 — HemoTrol WB - Low, HemoTrol WB - Normal, HemoTrol WB - High (February 1, 2019)
  • K152553 — CueSee Hypoxic (April 22, 2016)
  • K131595 — EUROTROL GAS-ISE HCT QC AND EUROTROL GAS-ISE HCT LVM (July 26, 2013)
  • K121467 — EUROTROL HEMATOCRIT CONTROL (May 10, 2013)
  • K060215 — ALBU TROL, LOW, MODEL 108.001.002; ALBU TROL, HIGH 108.002.002 (March 24, 2006)

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