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510(k) K050125

RAP/TAC/CSA CONTROL - LEVEL 1,2,3,4 by More Diagnostics — Product Code JJY

K050125 is an FDA 510(k) premarket notification submitted by More Diagnostics for the device "RAP/TAC/CSA CONTROL - LEVEL 1,2,3,4". The FDA issued a decision of Substantially Equivalent on March 18, 2005. The device falls under product code JJY (Multi-Analyte Controls, All Kinds (Assayed)), a Class I device regulated under 21 CFR 862.1660. More Diagnostics has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 18, 2005
Date Received
January 19, 2005
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 More Diagnostics

  • K072257 — MYCOPHENOLIC ACID CONTROL, LEVEL 1, 2, 3, 4, 4-LEVEL (January 30, 2008)
  • K982845 — CARDIAC MARKERS CONTROL (SINGLE USE)-LEVELS, 1,2,3, MODELS NUMBER 175-1, 175-2, (August 21, 1998)
  • K980331 — IMMUNOSUPPRESSANT (WHOLE BLOOD) CONTROL, LEVEL 1 250-1, IMMUNOSUPPRESSANT (WHOLE (March 16, 1998)
  • K972976 — CARDIAC MARKERS CONTROL - LEVEL 1, LEVEL 2, LEVEL 3, TRI-LEVEL (August 29, 1997)
  • K970778 — LEAD CONTROL (WHOLE BLOOD) LEVELS 1,2,3,4 (April 17, 1997)
  • K946193 — FIBRINOGEN CONTROL (HUMAN) LEVEL 1, 2, 3 (August 24, 1995)
  • K943571 — MULTI-LEVEL CONTROL FOR FIBRIN DEGRADATION PRODUCTS (June 15, 1995)
  • K944999 — SERUM BILIRUBIN CONTROL- LEVEL 1, 2 AND 3 (June 6, 1995)
  • K941876 — WHOLE BLOOD VOLATILES CONTROL, LEVELS 1 AND 2 (July 28, 1994)
  • K941698 — SERUM VOLATILES CONTROL - LEVELS 1 AND 2 (July 28, 1994)

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