LAW · Class I · 21 CFR 862.3280

FDA Product Code LAW: Theophylline Control Materials

Leading manufacturers include Sigma Chemical Co., Biotrack, Inc. and Invacare Corp..

4
Total
4
Cleared
87d
Avg days
1987
Since

FDA 510(k) Cleared Theophylline Control Materials Devices (Product Code LAW)

4 devices
1–4 of 4
Cleared Jun 10, 1992
CHEM CHEX THEOPHYLLINE CONTROL
K920223
Streck Laboratories, Inc.
Toxicology · 145d
Cleared Jan 24, 1992
MODEL IRC PASSPORT NEBULIZER
K914251
Invacare Corp.
Toxicology · 123d
Cleared Sep 17, 1990
BIOTRACK THEOPHYLLINE QUALITY CONTROLS
K903924
Biotrack, Inc.
Toxicology · 24d
Cleared Jun 17, 1987
THEOPHYLLINE FPIA CONTROLS
K871589
Sigma Chemical Co.
Toxicology · 54d

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