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

Bilirubin (Total And Unbound) In The Neonate Test System

21 CFR 862.1113 / Clinical Chemistry
FDA source (opens on fda.gov)

MQM is the FDA product code for Bilirubin (Total And Unbound) In The Neonate Test System, a class I device type, regulated under 21 CFR 862.1113. As of , FDA records hold 17 510(k) clearances under this code, the most recent dated , and 6 recalls.

Classification record

Product code
MQM
Device name
Bilirubin (Total And Unbound) In The Neonate Test System
Regulation
21 CFR 862.1113
Device class
Class I
Review panel
Clinical Chemistry
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
17
Ingested recalls
6

Clearances, product code MQM

By decision year
17 clearances under product code MQM with a decision year between 1992 and 2017, 1998 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code MQM by decision year
YearClearances
19921
19971
19983
19991
20001
20012
20031
20041
20051
20081
20111
20142
20171

Applicants with the most clearances

Product code MQM
Applicants holding the most 510(k) clearances under product code MQM
ApplicantClearances
Chromatics Color Sciences Intl., Inc.2
Radiometer Medical ApS2
Respironics, Inc.2
Siemens Healthcare Diagnostics Inc.2
Abbott Medical1
Air-Shields, Inc.1
Draeger Medical Infant Care, Inc.1
Draeger Medical Systems, Inc.1
Hill-Rom Air-Shields1
Instrumentation Laboratory Co.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 31 companies shown, in name order