LCA · Class II · 21 CFR 862.3880

FDA Product Code LCA: Radioimmunoassay, Theophylline

Leading manufacturers include Ria Diagnostics, Bioclinical Corp. and Kallestad Laboratories, Inc..

5
Total
5
Cleared
62d
Avg days
1980
Since

FDA 510(k) Cleared Radioimmunoassay, Theophylline Devices (Product Code LCA)

5 devices
1–5 of 5
Cleared Mar 24, 1988
THEOPHYLLINE TEST KIT REF. #A874799
K880291
Photec Diagnostics, Inc.
Chemistry · 59d
Cleared Jan 24, 1984
PHASE II THEOPHYLLINE RADIOIMMUNOASSAY
K833789
Medical & Scientific Designs, Inc.
Chemistry · 85d
Cleared Jul 06, 1982
QUANTICOAT 125 I-THEOPHYLLINE RADIOIMM.
K821862
Kallestad Laboratories, Inc.
Chemistry · 12d
Cleared May 28, 1982
BIO-MAG THEOPHYLLINE (125I) RADIOIMMUN.
K821347
Bioclinical Corp.
Chemistry · 23d
Cleared Feb 25, 1980
THEOPHYLLINE RIASSAY
K792062
Ria Diagnostics
Toxicology · 133d

About Product Code LCA - Regulatory Context