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

Test, Follicle Stimulating Hormone (Fsh), Over The Counter

21 CFR 862.1300 / Clinical Chemistry
FDA source (opens on fda.gov)

NGA is the FDA product code for Test, Follicle Stimulating Hormone (Fsh), Over The Counter, a class I device type, regulated under 21 CFR 862.1300. As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and 2 recalls.

Classification record

Product code
NGA
Device name
Test, Follicle Stimulating Hormone (Fsh), Over The Counter
Regulation
21 CFR 862.1300
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
2

Clearances, product code NGA

By decision year
2 clearances under product code NGA with a decision year between 2003 and 2007, 2003 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code NGA by decision year
YearClearances
20031
20071

Applicants with the most clearances

Product code NGA
Applicants holding the most 510(k) clearances under product code NGA
ApplicantClearances
Genosis, Ltd.1
Quantrx Biomedical Corporation1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 67 companies shown, in name order