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

Autoantibodies, Glutamic Acid Decarboxylase (Gad)

21 CFR 866.5660 / Immunology
FDA source (opens on fda.gov)

NWG is the FDA product code for Autoantibodies, Glutamic Acid Decarboxylase (Gad), a class II device type, regulated under 21 CFR 866.5660. FDA's definition for this code reads: "The device is used for the semi-quantitative determination of glutamic acid decarboxylase (GAD) autoantibodies in human serum as an aid in the diagnosis of Type I diabetes mellitus (autoimmune mediated diabetes)". As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
NWG
Device name
Autoantibodies, Glutamic Acid Decarboxylase (Gad)
FDA definition
The device is used for the semi-quantitative determination of glutamic acid decarboxylase (GAD) autoantibodies in human serum as an aid in the diagnosis of Type I diabetes mellitus (autoimmune mediated diabetes).
Regulation
21 CFR 866.5660
Device class
Class II
Review panel
Immunology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
2
Ingested recalls
0

Clearances, product code NWG

By decision year
2 clearances under product code NWG with a decision year between 2005 and 2007, 2005 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code NWG by decision year
YearClearances
20051
20071

Applicants with the most clearances

Product code NWG
Applicants holding the most 510(k) clearances under product code NWG
ApplicantClearances
Kronus Market Development Associates, Inc.2

Companies listing this code with FDA

Companies whose registered establishments list this code