Home / 510(k) Clearances / K980331

510(k) K980331

IMMUNOSUPPRESSANT (WHOLE BLOOD) CONTROL, LEVEL 1 250-1, IMMUNOSUPPRESSANT (WHOLE BLOOS) CONTROL, LEVEL 2, 250-2, IMMUN\S by More Diagnostics — Product Code DIF

K980331 is an FDA 510(k) premarket notification submitted by More Diagnostics for the device "IMMUNOSUPPRESSANT (WHOLE BLOOD) CONTROL, LEVEL 1 250-1, IMMUNOSUPPRESSANT (WHOLE BLOOS) CONTROL, LEVEL 2, 250-2, IMMUN\S". The FDA issued a decision of Substantially Equivalent on March 16, 1998. The device falls under product code DIF (Drug Mixture Control Materials), a Class I device regulated under 21 CFR 862.3280. More Diagnostics has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 16, 1998
Date Received
January 28, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Drug Mixture Control Materials
Device Class
Class I
Regulation Number
862.3280
Review Panel
TX
Submission Type

Other clearances by More Diagnostics

  • K072257 — MYCOPHENOLIC ACID CONTROL, LEVEL 1, 2, 3, 4, 4-LEVEL (January 30, 2008)
  • K050125 — RAP/TAC/CSA CONTROL - LEVEL 1,2,3,4 (March 18, 2005)
  • K982845 — CARDIAC MARKERS CONTROL (SINGLE USE)-LEVELS, 1,2,3, MODELS NUMBER 175-1, 175-2, (August 21, 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 DIF

  • K153474 — Detectabuse Liquid Control Urine, Detectabuse Stat-Skreen Liquid Control Urine, (February 23, 2016)
  • K132688 — SALIVABUSE LIQUID ORAL FLUID CONTROL, SALIVABUSE LIQUID ORAL FLUID CONTROL, AU/N (December 16, 2013)
  • K132174 — MULTICHEM WBT (September 20, 2013)
  • K121122 — DETECTABUSE LIQUID CONTROL, DETECTABUSE STAT-SKREEN LIQUID CONTROL (July 3, 2012)
  • K121143 — LIQUICHEK WHOLE BLOOD IMMUNOSUPPRESSANT CONTROL TILEVEL (1,2 AND 3) (May 18, 2012)
  • K120504 — LIQUICHEK URINE TOXICOLOGY CONTROL, S10 & S10 MINIPAK, LIQUICHEK URINE TOXICOLOG (March 27, 2012)
  • K103656 — THERMO SCIENTIFIC MAS R DOA TOTAL (March 24, 2011)
  • K093577 — LIQUICHEK OPIATE CONTROL (March 12, 2010)
  • K080085 — MAS TOX CONTROL (April 30, 2008)
  • K080183 — CONTROL SET DAT I, CONTRL SET DAT II, CONTROL SET DAT III, CONTROL SET AMPHETAMI (March 25, 2008)

FDA data resources