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

Immunoassay For Detection Of Amniotic Fluid Protein(S).

21 CFR 862.1550 / Clinical Chemistry
FDA source (opens on fda.gov)

NQM is the FDA product code for Immunoassay For Detection Of Amniotic Fluid Protein(S)., a class I device type, regulated under 21 CFR 862.1550. FDA's definition for this code reads: "The test is for use by health care professionals to aid in the detection of fetal membrane rupture in pregnant women, when they report signs, symptoms or complaints suggestive of such rupture". As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and 3 recalls.

Classification record

Product code
NQM
Device name
Immunoassay For Detection Of Amniotic Fluid Protein(S).
FDA definition
The test is for use by health care professionals to aid in the detection of fetal membrane rupture in pregnant women, when they report signs, symptoms or complaints suggestive of such rupture.
Regulation
21 CFR 862.1550
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
2
Ingested recalls
3

Clearances, product code NQM

By decision year
2 clearances under product code NQM with a decision year between 2009 and 2011, 2009 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code NQM by decision year
YearClearances
20091
20111

Applicants with the most clearances

Product code NQM
Applicants holding the most 510(k) clearances under product code NQM
ApplicantClearances
Amnisure International, LLC1
Clinical Innovations, LLC1

Companies listing this code with FDA

Companies whose registered establishments list this code