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510(k) K843605

EMIT 700 METHAQUALONE ASSAY by Syva Co. — Product Code KXS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 5, 1984
Date Received
September 13, 1984
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

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  • K011528 — EMIT 2000 PHENOBARBITAL ASSAY, MODEL OSR4D229 (June 6, 2001)
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  • 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)
  • K921013 — SYVA EMIT II METHAQUALONE ASSAY (May 13, 1992)
  • 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)