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510(k) K103364

MISSION CLINICHECK ASSAYED CHEMISTRY CONTROLS, LEVEL 1, LEVEL 2, DUAL LEVEL by Diamond Diagnostics, Inc. — Product Code JJY

K103364 is an FDA 510(k) premarket notification submitted by Diamond Diagnostics, Inc. for the device "MISSION CLINICHECK ASSAYED CHEMISTRY CONTROLS, LEVEL 1, LEVEL 2, DUAL LEVEL". The FDA issued a decision of Substantially Equivalent on May 6, 2011. The device falls under product code JJY (Multi-Analyte Controls, All Kinds (Assayed)), a Class I device regulated under 21 CFR 862.1660. Diamond Diagnostics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 6, 2011
Date Received
November 16, 2010
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 Diamond Diagnostics, Inc.

  • K200544 — SmartLyte® Plus Electrolyte Analyzer Na+/K+/Cl-/Ca++/Li+ (October 1, 2020)
  • K133751 — DIAMOND DIAGNOSTICS ISE SERUM STANDARDS, DIAMOND DIAGNOSTICS ISE URINE STANDARDS (August 8, 2014)
  • K124009 — MISSION CLINICHECK ASSAYED CHEMISTRY CONTROLS, LEVEL 1, MISSION CLINICHECK ASSAY (April 17, 2013)
  • K121027 — DIAMOND CALIBRATOR LOW, DIAMOND CALIBRATOR HIGH (December 20, 2012)
  • K121040 — SMARTLYTE ELECTROLYTE ANALYZER (August 30, 2012)
  • K121140 — PROLYTE ELECTROLYTE ANALYZER (August 22, 2012)
  • K120591 — DIAMOND TOKYO BOEKI ISE MODULE CALIBRATOR 1,2,1-2 (April 17, 2012)
  • K102959 — PROLYTE ELECTROLYTE ANALYZER (January 14, 2011)
  • K093357 — DIAMOND MEDICA ISE MODULE CALIBRANT A MODEL ME-6370D, DIAMOND MEDICA ISE MODULE (June 24, 2010)
  • K093492 — MISSION CLINICHECK ASSAYED CHEMISTRY CONTROL, LEVEL 1&2, MISSION CLINICAL CALIBR (March 19, 2010)

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