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510(k) K012855

LIQUISPX LIQUID LIPID CONTROL by Clinical Controls Division — Product Code JJY

K012855 is an FDA 510(k) premarket notification submitted by Clinical Controls Division for the device "LIQUISPX LIQUID LIPID CONTROL". The FDA issued a decision of Substantially Equivalent on Aug 30, 2001. The device falls under product code JJY (Multi-Analyte Controls, All Kinds (Assayed)), a Class I device regulated under 21 CFR 862.1660.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
Aug 30, 2001
Date Received
Aug 24, 2001
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
510(k) Exempt

Other clearances for product code JJY

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

FDA data resources

Source: FDA 510(k) database entry for K012855. Report a data issue: hello@regdatalab.com.