LER · Class II · 21 CFR 862.3880

FDA Product Code LER: Fluorescent Immunoassay, Theophylline

Leading manufacturers include Miles Laboratories, Inc., Bio-Rad and Syva Co..

15
Total
15
Cleared
45d
Avg days
1981
Since

FDA 510(k) Cleared Fluorescent Immunoassay, Theophylline Devices (Product Code LER)

15 devices
1–15 of 15
Cleared Jul 13, 1994
THEOPHYLLINE FPIA REAGENT SET AND CALIBRATORS
K942192
Sigma Diagnostics, Inc.
Chemistry · 70d
Cleared Dec 26, 1990
CEDIA(R) THEOPHYLLINE ASSAY/MODIFICATION
K905521
Microgenics Corp.
Toxicology · 19d
Cleared Nov 10, 1988
TURBOX THEOPHYLLINE ASSAY
K882570
Unipath , Ltd.
Toxicology · 141d
Cleared Dec 22, 1986
IMMPULSE COATED TUBE THEOPHYLLINE ASSAY REAGENTS
K864409
Sclavo, Inc.
Toxicology · 42d
Cleared Nov 05, 1986
THEOFAST(TM) TEST PACKAGE
K863475
3M Company
Chemistry · 57d
Cleared Nov 14, 1983
TDX THEOPHYLLINE
K833070
Abbott Laboratories
Toxicology · 67d
Cleared Jun 30, 1983
AMWA TDA THEOPHYLLINE TEST
K831514
Miles Laboratories, Inc.
Toxicology · 49d
Cleared Jan 07, 1983
COBAS STANDARD FOR TOTAL PROTEIN
K823576
Hoffmann-La Roche, Inc.
Chemistry · 32d
Cleared Mar 02, 1982
AMERIFLUOR THEOPHYLLINE FLUORESCENT IMM
K820397
American Diagnostic Corp.
Chemistry · 19d
Cleared Dec 03, 1981
EMIT-AAD THEOPHYLLINE ASSAY
K813240
Syva Co.
Toxicology · 16d
Cleared Sep 23, 1981
AMES TDA THEOPHYLLINE TEST
K812518
Miles Laboratories, Inc.
Chemistry · 21d
Cleared Jul 10, 1981
FLUOROMATIC THEOPHYLLINE FIA
K811856
Bio-Rad
Chemistry · 9d
Cleared Apr 17, 1981
AMES TDA THEOPHYLLINE TEST
K810943
Miles Laboratories, Inc.
Toxicology · 10d

About Product Code LER - Regulatory Context