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510(k) K920314

TXIT D.A.U. BARBITURATE ASSAY (MODIFICATION) by Syntex Corp. — Product Code DIS

K920314 is an FDA 510(k) premarket notification submitted by Syntex Corp. for the device "TXIT D.A.U. BARBITURATE ASSAY (MODIFICATION)". The FDA issued a decision of Substantially Equivalent on April 17, 1992. The device falls under product code DIS (Enzyme Immunoassay, Barbiturate), a Class II device regulated under 21 CFR 862.3150. Syntex Corp. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 17, 1992
Date Received
January 23, 1992
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 Syntex Corp.

  • K843593 — SURGIPRESS SURGICAL LOOP (October 24, 1984)
  • K780997 — AMALGAM ALLOY (July 27, 1978)
  • K780769 — S-100 CT SCANNER (June 2, 1978)
  • K780483 — FIBER OPTIC HANDPIECE (April 28, 1978)
  • K761331 — OPUS I OPTION - FIBER OPTIC L SYSTEM (January 3, 1977)
  • K761332 — HI-SENSITIVITY MODE OPTION FOR S60-1A (December 30, 1976)
  • K761330 — SYNTEX SYSTEM 6000 (December 30, 1976)
  • K761264 — OPTIONS FOR STAR DENTAL OPUS I (December 23, 1976)
  • K761033 — COMPUTERIZED TOMOGRAPHY SCANNER (November 24, 1976)

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)
  • K070009 — AT HOME DRUG TEST MODELS, 9308T AND 9308X (December 7, 2007)
  • K070098 — QUICKSCREEN BARBITURATE 300 SCREENING TEST, MODELS 9019, 9018; MULTI DRUG SCREEN (December 7, 2007)

FDA data resources