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510(k) K012257

EMIT II PLUS MONOCLONAL AMPHETAMINE/METHAMPHETAMINE ASSAY MODEL OSR9C229 by Syva Co. — Product Code DKZ

K012257 is an FDA 510(k) premarket notification submitted by Syva Co. for the device "EMIT II PLUS MONOCLONAL AMPHETAMINE/METHAMPHETAMINE ASSAY MODEL OSR9C229". The FDA issued a decision of Substantially Equivalent on August 3, 2001. The device falls under product code DKZ (Enzyme Immunoassay, Amphetamine), a Class II device regulated under 21 CFR 862.3100. Syva Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 3, 2001
Date Received
July 18, 2001
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Immunoassay, Amphetamine
Device Class
Class II
Regulation Number
862.3100
Review Panel
TX
Submission Type

Other clearances by Syva Co.

  • K011878 — EMIT (R) TOX SALICYLIC ASSAY, MODEL 7SO19UL, EMIT (R) TOX SALICYLIC ACID CALIBRA (August 13, 2001)
  • K011947 — EMIT 2000 VALPROIC ACID ASSAY, MODEL OSR4G229UL (July 2, 2001)
  • K011528 — EMIT 2000 PHENOBARBITAL ASSAY, MODEL OSR4D229 (June 6, 2001)
  • K011347 — EMIT 2000 PHENYTOIN ASSAY, MODEL 0SR4A229 (May 17, 2001)
  • K993981 — SYVA EMIT II PLUS PROPOXYPHENE ASSAY, MODELS 9G029UL/9G129UL (February 1, 2000)
  • K993980 — SYVA EMIT II PLUS ETHYL ALCOHOL ASSAY, MODELS 9K309UL/9K409UL (February 1, 2000)
  • K993029 — ABBOTT AEROSET THEOPHYLLINE ASSAY AND CALIBRATORS; MODELS 1E09 AND 6E89 (January 27, 2000)
  • K993988 — SYVA EMIT II PLUS COCAINE METABOLITE ASSAY, MODEL 9H029UL (January 27, 2000)
  • K993031 — ABBOTT AEROSET PHENOBARBITAL ASSEY AND CALIBRATORS;MODELS 1E08 AND 5F54 (January 27, 2000)
  • K993985 — SYVA EMIT II PLUS BENZODIAZEPINE ASSAY, MODELS 9F029UL/9F129UL (January 27, 2000)

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  • K231137 — Xenta Drug Screen Cup, Xenta Drug Screen Dipcard (May 19, 2023)
  • K200363 — Quidel Triage® TOX Drug Screen, 94600 (March 11, 2020)
  • K191099 — Atlas Multi-Drugs Screening Test Cup, Atlas Multi-Drugs Screening Test Panel (October 3, 2019)
  • K182719 — Quidel Triage TOX Drug Screen, 94600; Quidel Triage® MeterPro (June 19, 2019)
  • K182738 — Single and Multi-Drug Rapid Test Panel With Adulteration (Urine), Single and Mul (March 27, 2019)
  • K180879 — BIO-VENTURE Rapid Multi-Drug Test Easy Cup for OTC Use, BIO-VENTURE Rapid Multi- (December 14, 2018)
  • K181945 — QuickScreen Pro Multi Drug Screening Test, Model 9395Z (October 18, 2018)
  • K173303 — INSTANT-VIEW plus Multi-Drug of Abuse Urine Test - Simple Cup (OTC Use), INSTANT (February 23, 2018)

FDA data resources