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

System, Test, Low Density, Lipoprotein

21 CFR 862.1475 / Clinical Chemistry
FDA source (opens on fda.gov)

MRR is the FDA product code for System, Test, Low Density, Lipoprotein, a class I device type, regulated under 21 CFR 862.1475. As of , FDA records hold 31 510(k) clearances under this code, the most recent dated , and 9 recalls.

Classification record

Product code
MRR
Device name
System, Test, Low Density, Lipoprotein
Regulation
21 CFR 862.1475
Device class
Class I
Review panel
Clinical Chemistry
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
31
Ingested recalls
9

Clearances, product code MRR

By decision year
31 clearances under product code MRR with a decision year between 1990 and 2024, 1998 the highest year at 5.
Show the numbers
510(k) clearances under FDA product code MRR by decision year
YearClearances
19901
19931
19951
19963
19985
19993
20001
20011
20024
20043
20052
20081
20092
20171
20231
20241

Applicants with the most clearances

Product code MRR
Applicants holding the most 510(k) clearances under product code MRR
ApplicantClearances
Reference Diagnostics, Inc.4
Siemens Healthcare Diagnostics Inc.3
Genzyme Corporation3
Randox Laboratories, Limited2
Abbott Medical1
Alfa Wassermann1
Denka Seiken Co., Ltd.1
Sekisui Diagnostics P.E.I. Inc.1
Elan Diagnostics1
Hemagen Diagnostics, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 30 companies shown, in name order