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510(k) K955155

DOCUMENT TDM ULTRA UNASSAYED CONTROL by Casco Standards — Product Code DIF

K955155 is an FDA 510(k) premarket notification submitted by Casco Standards for the device "DOCUMENT TDM ULTRA UNASSAYED CONTROL". The FDA issued a decision of Substantially Equivalent on December 20, 1995. The device falls under product code DIF (Drug Mixture Control Materials), a Class I device regulated under 21 CFR 862.3280. Casco Standards has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 20, 1995
Date Received
November 13, 1995
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 Casco Standards

  • K981436 — DOCUMENT AMMONIA/ETHANOL/LACTATE CALIBRATOR, PN: M-109 (April 24, 1998)
  • K972904 — DOCUMENT MOLECULAR PATHOLOGY CHLAMYDIA TRACHOMATIS CONTROL (February 20, 1998)
  • K962629 — DOCUMENT AMMONIA, ETHANOL, LACTATE CALIBRATOR (September 13, 1996)
  • K962630 — DOCUMENT AMMONIA, ETHANOL, LACTATE ASSAYED CONTROL (July 22, 1996)
  • K961750 — DOCUMENT CARDIAC ASSAYED CONTROL (July 22, 1996)
  • K960244 — DOCUMENT TDM ULTRA ASSAYED CONTROL (March 22, 1996)
  • K950469 — DOCUMENT SERUM MULTIANALYTE CALIBRATION VERIFICATION TEST SET (April 11, 1995)
  • K945718 — DOCUMENT(R) HDL CHOLESTEROL CALIBRATION VERIFICATION TEST SET (January 17, 1995)
  • K945315 — DOCUMENT(R) AMMONIA/ETHANOL AQUEOUS CONTROL (December 9, 1994)
  • K944361 — DOCUMENT R AMMONIA/ETHANOL CONTROL (November 30, 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