LDP · Class II · 21 CFR 862.3030

FDA Product Code LDP: Colorimetry, Acetaminophen

Leading manufacturers include Diagnostic Chemicals , Ltd., Sekisui Diagnostics P.E.I., Inc. and Stanbio Laboratory.

37
Total
37
Cleared
96d
Avg days
1980
Since
37 devices
25–37 of 37
Cleared Jan 18, 1985
EMIT QST ACETAMINOPHEN ASSAY
K844962
Syva Co.
Toxicology · 25d
Cleared Aug 16, 1984
ACA ACETAMINOPHEN ANALYTICAL TEST PACK
K842548
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 45d
Cleared May 11, 1984
TDX ACETAMINOPHEN
K840941
Abbott Laboratories
Toxicology · 67d
Cleared Oct 04, 1983
ACETAMINOPHER ASSAY KIT
K832045
Quantimetrix Corp.
Toxicology · 102d
Cleared Aug 24, 1982
PROCEDURE #430 & REAGENTS FOR ACETAMIN
K822313
Sigma Chemical Co.
Chemistry · 21d
Cleared May 28, 1982
EMIT-TOX ACETAMINOPHEN ASSAY
K821379
Syva Co.
Toxicology · 18d
Cleared Jun 20, 1980
STANBIO ACETAMINOPHEN TEST SET #0850
K801014
Stanbio Laboratory
Toxicology · 53d