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

Enzyme Immunoassay, Cortisol, Salivary

21 CFR 862.1205 / Clinical Chemistry
FDA source (opens on fda.gov)

NHG is the FDA product code for Enzyme Immunoassay, Cortisol, Salivary, a class II device type, regulated under 21 CFR 862.1205. FDA's definition for this code reads: "The HS Salivary Cortisol Enzyme Immunoassay Kit is for the quantitative in vitro diagnostic measurement of salivary cortisol. This kit may be used to measure adrenal cortical function and as a screen for Cushing's and Addison's Disease. This kit is not intended for use with serum or plasma samples. The device's...". As of , FDA records hold 7 510(k) clearances under this code, the most recent dated , and 5 recalls.

Classification record

Product code
NHG
Device name
Enzyme Immunoassay, Cortisol, Salivary
FDA definition
The HS Salivary Cortisol Enzyme Immunoassay Kit is for the quantitative in vitro diagnostic measurement of salivary cortisol. This kit may be used to measure adrenal cortical function and as a screen for Cushing's and Addison's Disease. This kit is not intended for use with serum or plasma samples. The device's intended use differs from the description in the classification regulation in that it is for use with saliva samples.
Regulation
21 CFR 862.1205
Device class
Class II
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
7
Ingested recalls
5

Clearances, product code NHG

By decision year
7 clearances under product code NHG with a decision year between 2001 and 2015, 2001 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code NHG by decision year
YearClearances
20011
20031
20041
20051
20071
20121
20151

Applicants with the most clearances

Product code NHG
Applicants holding the most 510(k) clearances under product code NHG
ApplicantClearances
Roche Diagnostics GmbH2
Salimetrics LLC.2
Drg Intl., Inc.1
Ibl International GmbH1
Pantex, Div. Bio-Analysis, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code