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

Test System, Nicotine, Cotinine, Metabolites

21 CFR 862.3220 / Clinical Toxicology
FDA source (opens on fda.gov)

MRS is the FDA product code for Test System, Nicotine, Cotinine, Metabolites, a class I device type, regulated under 21 CFR 862.3220. As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
MRS
Device name
Test System, Nicotine, Cotinine, Metabolites
Regulation
21 CFR 862.3220
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
3
Ingested recalls
1

Clearances, product code MRS

By decision year
3 clearances under product code MRS with a decision year between 1996 and 2003, 1996 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code MRS by decision year
YearClearances
19961
20021
20031

Applicants with the most clearances

Product code MRS
Applicants holding the most 510(k) clearances under product code MRS
ApplicantClearances
Dynagen, Inc.1
Microgenics Corporation1
Nymox Pharmaceutical Corporation1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 31 companies shown, in name order