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510(k) K864456

CYCLOSPORIN A (WHOLE BLOOD) CONTROL - LEVELS 1,2,3 by Cala Diagnostics — Product Code LAS

K864456 is an FDA 510(k) premarket notification submitted by Cala Diagnostics for the device "CYCLOSPORIN A (WHOLE BLOOD) CONTROL - LEVELS 1,2,3". The FDA issued a decision of Substantially Equivalent on May 6, 1987. The device falls under product code LAS (Drug Specific Control Materials), a Class I device regulated under 21 CFR 862.3280. Cala Diagnostics has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 6, 1987
Date Received
November 13, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by Cala Diagnostics

  • K944246 — CARDIOCHEX CKMB MASS MEASUREMENT CONTROL (October 31, 1994)
  • K944247 — CARDIOCHEX CKMB IMMUNOINHIBITION CONTROL (October 31, 1994)
  • K944243 — CARDIOCHEX (October 27, 1994)
  • K930874 — LD-1 CONTROL-LEVEL 1 & 2 (April 22, 1993)
  • K930873 — CKMB ISOENZYME CONTROL-LEVEL 1,2.3 (April 13, 1993)
  • K930875 — CKMB CONTROL - LEVEL 1,2,3 (April 13, 1993)
  • K926015 — CKMB CONTROL FOR MASS MEASUREMENT-LEVELS 1,2,3 (December 28, 1992)
  • K915503 — FIBRINOGEN FDP CONTROL (January 30, 1992)
  • K912827 — SERUM ALCOHOL CONTROL LEVELS 1, 2 & 3 (August 12, 1991)
  • K912826 — WHOLE BLOOD ALCOHOL CONTROL, LEVEL 1 & 2 (July 26, 1991)

Other clearances for product code LAS

  • K080459 — CHROMESYTEMS TOXICOLOGY CALIBRATORS AND CONTROLS (November 17, 2009)
  • K072257 — MYCOPHENOLIC ACID CONTROL, LEVEL 1, 2, 3, 4, 4-LEVEL (January 30, 2008)
  • K062942 — QUANTIMETRIX NICOSURE COTININE URINE CONTROL (October 30, 2006)
  • K051074 — MAS IMMUNOSUPPRESSANT CONTROLS (June 6, 2005)
  • K040411 — DRI OXYCODONE ASSAY (May 27, 2004)
  • K032842 — MICROGENICS CYCLOSPORINE CONTROL KIT (October 17, 2003)
  • K030616 — CEDIA CYCLOSPORINE PLUS HIGH RANGE CONTROLS 4 AND 5 (March 31, 2003)
  • K992151 — REFERENCE MATERIAL FOR DELTA-9-THC-COOH IN HUMAN URINE (July 14, 1999)
  • K970517 — INNOFLUOR TOPIRAMATE CONTROL SET (May 12, 1997)
  • K971210 — SYNCHRON SYSTEMS 10 NG/ML & 40 NG/ML THC URINE CONTROLS (April 17, 1997)

FDA data resources