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

Radioimmunoassay, Cannabinoid(S)

21 CFR 862.3870 / Clinical Toxicology
FDA source (opens on fda.gov)

LAT is the FDA product code for Radioimmunoassay, Cannabinoid(S), a class II device type, regulated under 21 CFR 862.3870. As of , FDA records hold 16 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
LAT
Device name
Radioimmunoassay, Cannabinoid(S)
Regulation
21 CFR 862.3870
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
16
Ingested recalls
0

Clearances, product code LAT

By decision year
16 clearances under product code LAT with a decision year between 1978 and 2002, 1991 the highest year at 5.
Show the numbers
510(k) clearances under FDA product code LAT by decision year
YearClearances
19781
19791
19801
19823
19842
19915
19962
20021

Applicants with the most clearances

Product code LAT
Applicants holding the most 510(k) clearances under product code LAT
ApplicantClearances
Immunalysis Corporation7
Roche Diagnostic Systems, Inc.4
Siemens Healthcare Diagnostics Inc.1
Hoffmann-La Roche, Inc.1
Psychemedics Corp.1
Sudormed, Inc.1
Syva Co.1

Companies listing this code with FDA

Companies whose registered establishments list this code

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