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510(k) K800246

EMIT -D.A.U. CANNABINOID URINE ASSAY by Syva Co. — Product Code LAT

K800246 is an FDA 510(k) premarket notification submitted by Syva Co. for the device "EMIT -D.A.U. CANNABINOID URINE ASSAY". The FDA issued a decision of Substantially Equivalent on February 26, 1980. The device falls under product code LAT (Radioimmunoassay, Cannabinoid(S)), a Class II device regulated under 21 CFR 862.3870. Syva Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 26, 1980
Date Received
February 5, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Cannabinoid(S)
Device Class
Class II
Regulation Number
862.3870
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)
  • K012257 — EMIT II PLUS MONOCLONAL AMPHETAMINE/METHAMPHETAMINE ASSAY MODEL OSR9C229 (August 3, 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)
  • K993980 — SYVA EMIT II PLUS ETHYL ALCOHOL ASSAY, MODELS 9K309UL/9K409UL (February 1, 2000)
  • K993981 — SYVA EMIT II PLUS PROPOXYPHENE ASSAY, MODELS 9G029UL/9G129UL (February 1, 2000)
  • K993985 — SYVA EMIT II PLUS BENZODIAZEPINE ASSAY, MODELS 9F029UL/9F129UL (January 27, 2000)
  • K993031 — ABBOTT AEROSET PHENOBARBITAL ASSEY AND CALIBRATORS;MODELS 1E08 AND 5F54 (January 27, 2000)
  • K993982 — SYVA EMIT II PLUS AMPHETAMINE/METHAMPHETAMINE ASSAY 9C029UL/9C129UL (January 27, 2000)

Other clearances for product code LAT

  • K011426 — PSYCHEMEDICS RIA CANNABINOID ASSAY (May 3, 2002)
  • K961620 — ABISCREEN ONLINE FOR CANNABINOIDS - ES 50/100 (June 13, 1996)
  • K936135 — SUDORMED SWEAT PATCH SPECIMEN CONTAINER FOR COLLECTION OF MARIJUANA IN PERSPIRAT (June 10, 1996)
  • K914507 — DOUBLE ANTIBODY CANNABIONOIDS/QUAIL DETER IN URINE (December 18, 1991)
  • K913414 — ABUSCREEN(R) ONLINE(TM) FOR THC(50/100)(100TEST KT (September 25, 1991)
  • K913865 — URINE THC DIRECT RIA KIT (I-125) (September 18, 1991)
  • K912574 — ABUSCREEN ONLINE FOR THC (50 AND 100) (August 12, 1991)
  • K904996 — ABUSCREEN ONLINE TM FOR THC (January 11, 1991)
  • K843534 — ORAL THC-CANNABINOIDS DIRECT RIA KIT (October 30, 1984)
  • K833911 — URINE THC CANNABINOIDS DIRECT RIA KIT (January 24, 1984)

FDA data resources