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510(k) K941489

ACE CLINICAL CHEMISTRY SYSTEM by Schiapparelli Biosystems, Inc. — Product Code DIS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 18, 1994
Date Received
March 28, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Immunoassay, Barbiturate
Device Class
Class II
Regulation Number
862.3150
Review Panel
TX
Submission Type

Other clearances by Schiapparelli Biosystems, Inc.

  • K991733 — ACE LDL-C REAGENT, LDL-C CALIBRATOR, LDL-C CONTROLS (July 13, 1999)
  • K981377 — ACE T4 REAGENT T4 CALIBRATORS (June 10, 1998)
  • K981375 — ACE T UPTAKE REAGENT TU CALIBRATORS (June 10, 1998)
  • K973581 — ACE VALPROIC ACID REAGENT, AED CALIBRATORS (November 12, 1997)
  • K973582 — ACE PRIMIDONE REAGENT, AED CALIBRATORS (November 12, 1997)
  • K973583 — ACE THEOPHYLLINE REAGENT, THEO CALIBRATORS (November 12, 1997)
  • K973536 — ACE PHENOBARBITAL REAGENT/AED CALIBRATORS (November 6, 1997)
  • K973414 — ACE PHENYTOIN REAGENT, AED CALIBRATORS (November 4, 1997)
  • K973535 — ACE CARBAMAZEPINE REAGENT/AED CALIBRATORS (October 20, 1997)
  • K971526 — ACE HDL-C REAGENT (May 21, 1997)

Other clearances for product code DIS

  • K161714 — Immunalysis Barbiturates Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibr (October 14, 2016)
  • K151211 — AssureTech Secobarbital Strip, AssureTech Oxycodone Strip, AssureTech Secobarbit (June 4, 2015)
  • K150791 — Healgen Secobarbital Test(Strip, Cassette, Cup, Dip Card), Healgen Burprenorphin (April 24, 2015)
  • K143535 — CR3 Keyless Split Sample Cup Secobarbital- Methadone (January 13, 2015)
  • K140665 — GenPrime Snap-Top Split Key Cup (December 8, 2014)
  • K140215 — ONE STEP SINGLE/MULTI-DRUG TEST CUP/DIPCARD (June 16, 2014)
  • K092268 — RANDOX BARITURATES ASSAY (May 25, 2011)
  • K110515 — UCP DRUG SCREENING TEST CUPS (April 20, 2011)
  • K070098 — QUICKSCREEN BARBITURATE 300 SCREENING TEST, MODELS 9019, 9018; MULTI DRUG SCREEN (December 7, 2007)
  • K070009 — AT HOME DRUG TEST MODELS, 9308T AND 9308X (December 7, 2007)