DIS · Class II · 21 CFR 862.3150

FDA Product Code DIS: Enzyme Immunoassay, Barbiturate

Leading manufacturers include Syva Co., Abbott Laboratories and Roche Diagnostic Systems, Inc..

100
Total
100
Cleared
97d
Avg days
1979
Since
100 devices
25–48 of 100
Cleared Nov 13, 1987
REVISED LABELING FOR ABUSCREEN EIA BARBITURATE
K874210
Roche Diagnostic Systems, Inc.
Toxicology · 28d
Cleared Nov 13, 1987
REVISED LABELING FOR BARBITURATE TEST KIT
K874266
Roche Diagnostic Systems, Inc.
Toxicology · 24d
Cleared Oct 20, 1987
ACA URINE BARBITURATES SCREEN METHOD
K873623
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 42d
Cleared Oct 15, 1987
LABELING CHANGE BARBITURATES IN URINE
K873754
Diagnostic Products Corp.
Toxicology · 41d
Cleared Mar 19, 1987
COAT-A-COUNT BARBITURATES TKBA1 AND TKBA5
K870936
Diagnostic Products Corp.
Toxicology · 10d
Cleared Mar 16, 1987
ABUSCREEN (R) EIA BARBITURATE
K870378
Roche Diagnostic Systems, Inc.
Toxicology · 46d
Cleared Sep 26, 1984
EMIT D.A.U. BARBITURATE ASSAY
K842675
Syva Co.
Toxicology · 78d
Cleared Sep 14, 1984
EMIT 700 BARBITURATE ASSAY
K843418
Syva Co.
Toxicology · 14d
Cleared Sep 07, 1984
ACA BARBITURATES SCREEN ANALY TEST PACK
K842783
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 52d
Cleared Mar 19, 1984
EMIT ST SERUM BARBITURATE ASSAY
K840194
Syva Co.
Toxicology · 61d
Cleared Jan 26, 1984
MODIF. OF EMIT URINE BARBITURATE
K833577
Syva Co.
Toxicology · 106d
Cleared Apr 03, 1981
EMIT-ST SERUM BARBITURATE ASSAY
K810602
Syva Co.
Toxicology · 28d
Cleared Oct 31, 1980
EMIT-STM BARBITURATE ASSAY
K802617
Syva Co.
Toxicology · 11d
Cleared Dec 04, 1979
EMIT-BARBITURATE ASSAY
K792114
Syva Co.
Toxicology · 39d