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

Test, Luteinizing Hormone (Lh), Over The Counter

21 CFR 862.1485 / Clinical Chemistry
FDA source (opens on fda.gov)

NGE is the FDA product code for Test, Luteinizing Hormone (Lh), Over The Counter, a class I device type, regulated under 21 CFR 862.1485. As of , FDA records hold 6 510(k) clearances under this code, the most recent dated , and 10 recalls.

Classification record

Product code
NGE
Device name
Test, Luteinizing Hormone (Lh), Over The Counter
Regulation
21 CFR 862.1485
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
6
Ingested recalls
10

Clearances, product code NGE

By decision year
6 clearances under product code NGE with a decision year between 1985 and 2002, 1998 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code NGE by decision year
YearClearances
19851
19861
19982
19991
20021

Applicants with the most clearances

Product code NGE
Applicants holding the most 510(k) clearances under product code NGE
ApplicantClearances
Unipath, Ltd.2
Conception Technology, Inc.1
Micron Technology, Inc.1
Pheromone Sciences Corp.1
Zetek, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 104 companies shown, in name order