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

Drug Specific Control Materials

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

LAS is the FDA product code for Drug Specific Control Materials, a class I device type, regulated under 21 CFR 862.3280. As of , FDA records hold 83 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
LAS
Device name
Drug Specific 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
83
Ingested recalls
1

Clearances, product code LAS

By decision year
83 clearances under product code LAS with a decision year between 1976 and 2009, 1979 the highest year at 10.
Show the numbers
510(k) clearances under FDA product code LAS by decision year
YearClearances
19761
19782
197910
19804
19815
19829
19836
19842
19865
19874
19881
19899
19916
19923
19933
19942
19951
19972
19991
20032
20041
20051
20061
20081
20091

Applicants with the most clearances

Product code LAS
Applicants holding the most 510(k) clearances under product code LAS
ApplicantClearances
Syva Co.19
Roche Diagnostic Systems, Inc.14
Utak Laboratories Inc8
Hemometrix6
Microgenics Corporation5
E.I. Dupont de Nemours & Co., Inc.3
Syva Co.3
Bio-Rad2
Consolidated Technologies, Inc.2
More Diagnostics Inc.2

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 21 companies shown, in name order