Atlas FDA

EMIT 700 METHAQUALONE ASSAY

FDA 510(k) clearance K843605 · decided 1984-10-05

Clearance details

K-number
K843605
Device name
EMIT 700 METHAQUALONE ASSAY
Applicant
Syva Co.
Decision
Substantially Equivalent
Date received
1984-09-13
Decision date
1984-10-05
Days to decision
22 days
Clearance type
Traditional
Product code
KXS
Device class
2
Regulation number
862.3630
Medical specialty
Clinical Toxicology
Advisory committee
Clinical Toxicology
Location
Walker, MI, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
MODIFICATION TO THE EMIT II PLUS METHAQUALONE ASSAY, MODEL OSR9Q229 (K011164)Syva Co., Dade Behring, Inc.2001-05-10
SYVA EMIT II PLUS METHAQUALONE ASSAY, MODEL 9Q029UL/9Q129UL (K993986)Syva Co.2000-01-27
SYNCHRON SYSTEMS METHAQUALONE REAGENT (K955676)Beckman Instruments, Inc.1996-03-04
ROCHE ABUSCREEN ONLINE FOR METHAQUALONE (K945187)Roche Diagnostic Systems, Inc.1995-04-05
METHAQUALONE ENZYME IMMUNOASSAY (K940123)Diagnostic Reagents, Inc.1994-05-03
SYVA EMIT II METHAQUALONE ASSAY (K921013)Syva Co.1992-05-13
REVISED LABELING FOR METHAQUALONE TEST KIT (K874272)Roche Diagnostic Systems, Inc.1987-11-13
REVISED LABELING FOR SYVA METHAQUALONE ASSAYS (K874199)Syva Co.1987-10-28
LABELING CHANGE COAT-A-COUNT METHAQUALONE (K873759)Diagnostic Products Corp.1987-10-15
COAT-A-COUNT METHAQUALONE TKMQ1 (K870935)Diagnostic Products Corp.1987-03-19
EMIT ST URINE METHAQUALONE ASSAY (K840164)Syva Co.1984-03-22
ABUSCREEN RADIOUMMUNOASSAY-METHAQUALONE (K830461)Hoffmann-La Roche, Inc.1983-03-24

Recalls involving this device

No recalls on record reference this clearance.