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510(k) K982745

AUTO-LYTE BARBITURATES EIA by OraSure Technologies, Inc. — Product Code DIS

K982745 is an FDA 510(k) premarket notification submitted by OraSure Technologies, Inc. for the device "AUTO-LYTE BARBITURATES EIA". The FDA issued a decision of Substantially Equivalent on November 18, 1998. The device falls under product code DIS (Enzyme Immunoassay, Barbiturate), a Class II device regulated under 21 CFR 862.3150. OraSure Technologies, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 18, 1998
Date Received
August 6, 1998
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 OraSure Technologies, Inc.

  • DEN190025 — OraQuick Ebola Rapid Antigen Test (October 10, 2019)
  • K060859 — COMPOUND W FREEZE OFF WART REMOVAL SYSTEM (July 18, 2006)
  • K023487 — HISTOFREEZER WART REMOVAL SYSTEM OR OTHER PROPRIETARY NAME (March 20, 2003)
  • K013882 — OTI BENZODIAZEPINES INTERCEPT MICRO-PLATE EIA MODEL #1110I (April 17, 2002)
  • K020371 — UPLINK TEST SYSTEM (April 3, 2002)
  • K011057 — INTERCEPT ORAL FLUID DRUG TEST ORAL SPECIMEN COLLECTION DEVICE, MODEL 503-XXXX (June 6, 2001)
  • K002375 — STC CANNABINOIDS INTERCEPT MICRO-PLATE EIA, MODEL 1118I (January 26, 2001)
  • K001976 — STC BARBITURATES INTERCEPT MICRO-PLATE EIA, MODEL 1108I (December 6, 2000)
  • K002010 — STC METHADONE INTERCEPT MICRO-PLATE EIA, MODEL 11421 (November 29, 2000)
  • K000399 — STC PCP INTERCEPT MICRO-PLATE EIA, MODEL 11541 (May 15, 2000)

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