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510(k) K802620

EMIT-STM ETHYL ALCOHOL URINE CALIBRATOR by Syva Co. — Product Code DNN

K802620 is an FDA 510(k) premarket notification submitted by Syva Co. for the device "EMIT-STM ETHYL ALCOHOL URINE CALIBRATOR". The FDA issued a decision of Substantially Equivalent on October 31, 1980. The device falls under product code DNN (Calibrators, Ethyl Alcohol), a Class II device regulated under 21 CFR 862.3200. Syva Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 31, 1980
Date Received
October 20, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calibrators, Ethyl Alcohol
Device Class
Class II
Regulation Number
862.3200
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)
  • 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)

Other clearances for product code DNN

  • K990516 — ETHYL ALCOHOL CLINICAL STANDARD SOLUTIONS (March 31, 1999)
  • K973054 — ETHYL ALCOHOL CLINICAL STANDARD SOLUTIONS (October 1, 1997)
  • K924733 — ETHYL ALCOHOL CALIBRATORS & CONTROL (December 9, 1992)
  • K882117 — ETHYL ALCOHOL STANDARD (August 4, 1988)
  • K853532 — ALCOHOL CALIBRATORS (September 16, 1985)
  • K810466 — ETHYL ALCOHOL SERUM CALIBRATOR (March 6, 1981)

FDA data resources