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510(k) K140522

RANDOX IMMUNOASSAY PREMIUM PLUS CONTROL LEVELS 1,2 AND LEVEL 3 AND IMMUNOASSAY PREMIUM PLUS TRI-LEVEL CONTROL by Randox Laboratories Limited — Product Code JJY

K140522 is an FDA 510(k) premarket notification submitted by Randox Laboratories Limited for the device "RANDOX IMMUNOASSAY PREMIUM PLUS CONTROL LEVELS 1,2 AND LEVEL 3 AND IMMUNOASSAY PREMIUM PLUS TRI-LEVEL CONTROL". The FDA issued a decision of Substantially Equivalent on May 22, 2014. The device falls under product code JJY (Multi-Analyte Controls, All Kinds (Assayed)), a Class I device regulated under 21 CFR 862.1660. Randox Laboratories Limited has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 22, 2014
Date Received
March 4, 2014
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 Randox Laboratories Limited

  • K250741 — Evidence MultiSTAT DOA Urine MultiPlex (January 23, 2026)
  • K220451 — Evidence MultiSTAT DOA Urine MultiPlex, Evidence MultiSTAT (October 5, 2023)
  • K221550 — Evidence MultiSTAT DOA Urine MultiPlex (October 5, 2023)
  • K162275 — Randox RX Daytona Plus Alkaline Phosphatase (ALP) (April 21, 2017)
  • K161691 — Direct LDL Cholesterol (LDL) (March 20, 2017)
  • K152343 — Direct Bilirubin (February 16, 2016)
  • K152344 — Total Bilirubin (January 28, 2016)
  • K150819 — Triglycerides (August 6, 2015)
  • K140971 — LIQUID ASSAYED CHEMISTRY CONTROL PREMIUM PLUS LEVEL 1,2 AND LEVEL 3. (December 8, 2014)
  • K142181 — RANDOX ALDOLASE CALIBRATION SERUM (September 18, 2014)

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