510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
LAFClass II

Gas Chromatography, Methamphetamine

21 CFR 862.3610 / Clinical Toxicology
FDA source (opens on fda.gov)

LAF is the FDA product code for Gas Chromatography, Methamphetamine, a class II device type, regulated under 21 CFR 862.3610. As of , FDA records hold 49 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
LAF
Device name
Gas Chromatography, Methamphetamine
Regulation
21 CFR 862.3610
Device class
Class II
Review panel
Clinical Toxicology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
49
Ingested recalls
1

Clearances, product code LAF

By decision year
49 clearances under product code LAF with a decision year between 1989 and 2021, 2000 the highest year at 8.
Show the numbers
510(k) clearances under FDA product code LAF by decision year
YearClearances
19891
19901
19911
19961
19971
19981
19992
20008
20018
20023
20032
20051
20061
20082
20114
20122
20142
20153
20161
20171
20201
20212

Applicants with the most clearances

Product code LAF
Applicants holding the most 510(k) clearances under product code LAF
ApplicantClearances
Phamatech Inc.4
Acon Laboratories, Inc.3
Siemens Healthcare Diagnostics Inc.3
Immunalysis Corporation3
Lin-Zhi International Inc3
Microgenics Corporation3
Alfa Scientific Designs, Inc.2
Biophor Diagnostics, Inc.2
Princeton BioMeditech Corp.2
Psychemedics Corp.2

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 60 companies shown, in name order