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510(k) K812987

AGGLUTEX METHAQUALONE TEST KIT by Hoffmann-La Roche, Inc. — Product Code KXS

K812987 is an FDA 510(k) premarket notification submitted by Hoffmann-La Roche, Inc. for the device "AGGLUTEX METHAQUALONE TEST KIT". The FDA issued a decision of Substantially Equivalent on December 22, 1981. The device falls under product code KXS (Radioimmunoassay, Methaqualone), a Class II device regulated under 21 CFR 862.3630. Hoffmann-La Roche, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 22, 1981
Date Received
October 26, 1981
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 Hoffmann-La Roche, Inc.

  • K850727 — BHCG-ROCHE EIA (June 25, 1985)
  • K831694 — RENAK (July 19, 1983)
  • K830460 — ABUSCREEN RADIOIMMUNOASSAY FOR MORPHINE (March 24, 1983)
  • K830481 — ABUSCREEN RADIOIMMUNOASSAY-PHENCYCLIDINE (March 24, 1983)
  • K830482 — ABUSCREEN RADIOIMMUNOASSAY-AMPHETAMINE (March 24, 1983)
  • K830480 — ABUSCREEN RADIOIMMUNOASSAY-COCAINE META (March 24, 1983)
  • K830461 — ABUSCREEN RADIOUMMUNOASSAY-METHAQUALONE (March 24, 1983)
  • K830462 — ABUSCREEN RADIOUMMUNOASSAY--URINE (March 24, 1983)
  • K830479 — ABUSCREEN RADIOIMMUNOASSAY-BARBITURATE (March 10, 1983)
  • K823578 — COBAS STANDARDS FOR CALCIUM-IN-ORGANIC (January 7, 1983)

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)

FDA data resources