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510(k) K974534

MICRO-PLATE COTININE EIA by OraSure Technologies, Inc. — Product Code MKU

K974534 is an FDA 510(k) premarket notification submitted by OraSure Technologies, Inc. for the device "MICRO-PLATE COTININE EIA". The FDA issued a decision of Substantially Equivalent on May 18, 1998. The device falls under product code MKU (Enzyme Immunoassay, Nicotine And Nicotine Metabolites), a Class I device regulated under 21 CFR 862.3220. OraSure Technologies, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 18, 1998
Date Received
December 2, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Immunoassay, Nicotine And Nicotine Metabolites
Device Class
Class I
Regulation Number
862.3220
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 MKU

  • K192517 — Psychemedics Microplate EIA for Cotinine in Hair (April 22, 2020)
  • K192299 — LZI Cotinine II Enzyme Immunoassay (November 21, 2019)
  • K062565 — STATUS DS NICOTINE, ACCUSIGN NICOTINE, BIOSIGN NICOTINE (February 20, 2007)
  • K021944 — COZART EIA COTININE URINE KIT (May 14, 2003)
  • K974234 — MICRO-PLATE COTININE EIA (May 14, 1998)
  • K972481 — AUTO-LYTE COTININE EIA (October 21, 1997)

FDA data resources