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510(k) K811461

EMIT-AND METHOTREXATE CONTROL by Syva Co. — Product Code LAZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 9, 1981
Date Received
May 26, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
N-Acetylprocainamide Control Materials
Device Class
Class I
Regulation Number
862.3280
Review Panel
TX
Submission Type

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  • 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)
  • K993983 — SYVA EMIT II PLUS PHENCYCLIDINE ASSAY, MODEL 9J029UL (January 27, 2000)
  • K993986 — SYVA EMIT II PLUS METHAQUALONE ASSAY, MODEL 9Q029UL/9Q129UL (January 27, 2000)

Other clearances for product code LAZ

  • K211667 — Disposable Medical Synthetic Nitrile Examination Gloves (Non-Sterile) (September 23, 2021)
  • K851474 — VYGON SPINAL ANESTHESIA TRAY CODE NO. 190 (May 7, 1985)
  • K823127 — ADVANCE EMIT-CAD PROCAINAMIDE/N-ACETYL (November 29, 1982)