FDA product code LAW: Theophylline Control Materials
LAW is the FDA product code for theophylline control materials. It is a Class I device, regulated under 21 CFR 862.3280 and reviewed by the Clinical Toxicology panel. FDA has cleared 4 510(k) submissions under LAW, from 4 different applicants. The average 510(k) review took 86 days (median 88).
Classification
| Field | Value |
|---|---|
| Device name | Theophylline Control Materials |
| Device class | Class I |
| Regulation | 21 CFR 862.3280 |
| Review panel | TX — Clinical Toxicology |
| Medical specialty | Clinical Toxicology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every LAW clearance
Top LAW applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Streck Laboratories, Inc. | 1 | 1992-06-10 |
| Invacare Corp. | 1 | 1992-01-24 |
| Biotrack, Inc. | 1 | 1990-09-17 |
| Sigma Chemical Co. | 1 | 1987-06-17 |
Most recent LAW clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K920223 | Streck Laboratories, Inc. | CHEM CHEX THEOPHYLLINE CONTROL | 1992-06-10 | 145 |
| K914251 | Invacare Corp. | MODEL IRC PASSPORT NEBULIZER | 1992-01-24 | 123 |
| K903924 | Biotrack, Inc. | BIOTRACK THEOPHYLLINE QUALITY CONTROLS | 1990-09-17 | 24 |
| K871589 | Sigma Chemical Co. | THEOPHYLLINE FPIA CONTROLS | 1987-06-17 | 54 |
Recalls for LAW devices
openFDA lists no recalls for product code LAW.
Frequently asked questions
What is FDA product code LAW?
LAW is the FDA product code for theophylline control materials. It is a Class I device, regulated under 21 CFR 862.3280 and reviewed by the Clinical Toxicology panel.
What device class is LAW?
Class I, regulation 21 CFR 862.3280. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code LAW?
Across 4 cleared submissions the average was 86 days from receipt to decision (median 88).
Which companies have the most LAW clearances?
Streck Laboratories, Inc. (1); Invacare Corp. (1); Biotrack, Inc. (1); Sigma Chemical Co. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code LAW
- Run a recall and safety report across every LAW manufacturer
- Watch product code LAW for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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