510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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LAWClass I

Theophylline Control Materials

21 CFR 862.3280 / Clinical Toxicology
FDA source (opens on fda.gov)

LAW is the FDA product code for Theophylline Control Materials, a class I device type, regulated under 21 CFR 862.3280. As of , FDA records hold 4 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
LAW
Device name
Theophylline Control Materials
Regulation
21 CFR 862.3280
Device class
Class I
Review panel
Clinical Toxicology
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
4
Ingested recalls
0

Clearances, product code LAW

By decision year
4 clearances under product code LAW with a decision year between 1987 and 1992, 1992 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code LAW by decision year
YearClearances
19871
19901
19922

Applicants with the most clearances

Product code LAW
Applicants holding the most 510(k) clearances under product code LAW
ApplicantClearances
Biotrack, Inc.1
Invacare GmbH1
Sigma Chemical Co.1
Streck Laboratories, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code LAW.