LAW · Class I · 21 CFR 862.3280

FDA Product Code LAW: Theophylline Control Materials

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

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

Streck Laboratories, Inc.

Toxicology · 145d

Cleared Jan 24, 1992

MODEL IRC PASSPORT NEBULIZER

Toxicology · 123d

Cleared Jun 17, 1987

THEOPHYLLINE FPIA CONTROLS

Sigma Chemical Co.

Toxicology · 54d

About Product Code LAW - Regulatory Context

Related FDA 510(k) Regulatory Insights

Data Source

FDA 510(k) public files . 175,730 total devices indexed.

Latest clearance: Jun 10, 1992

Product Code Info

Code	LAW
Device class	Class I
CFR	21 CFR 862.3280
Panel	Toxicology

Verify on FDA.gov

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