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510(k) K921013

SYVA EMIT II METHAQUALONE ASSAY by Syva Co. — Product Code KXS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 13, 1992
Date Received
March 3, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Methaqualone
Device Class
Class II
Regulation Number
862.3630
Review Panel
TX
Submission Type

Other clearances by Syva Co.

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  • 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)
  • 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 KXS

  • K011164 — MODIFICATION TO THE EMIT II PLUS METHAQUALONE ASSAY, MODEL OSR9Q229 (May 10, 2001)
  • K993986 — SYVA EMIT II PLUS METHAQUALONE ASSAY, MODEL 9Q029UL/9Q129UL (January 27, 2000)
  • K955676 — SYNCHRON SYSTEMS METHAQUALONE REAGENT (March 4, 1996)
  • K945187 — ROCHE ABUSCREEN ONLINE FOR METHAQUALONE (April 5, 1995)
  • K940123 — METHAQUALONE ENZYME IMMUNOASSAY (May 3, 1994)
  • K874272 — REVISED LABELING FOR METHAQUALONE TEST KIT (November 13, 1987)
  • K874199 — REVISED LABELING FOR SYVA METHAQUALONE ASSAYS (October 28, 1987)
  • K873759 — LABELING CHANGE COAT-A-COUNT METHAQUALONE (October 15, 1987)
  • K870935 — COAT-A-COUNT METHAQUALONE TKMQ1 (March 19, 1987)
  • K843605 — EMIT 700 METHAQUALONE ASSAY (October 5, 1984)