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

Immunoassay, Pregnanediol Glucuronide, Over The Counter

21 CFR 862.1620 / Clinical Chemistry
FDA source (opens on fda.gov)

QKE is the FDA product code for Immunoassay, Pregnanediol Glucuronide, Over The Counter, a class I device type, regulated under 21 CFR 862.1620. FDA's definition for this code reads: "Over-the-counter detection of pregnanediol glucuronide for the confirmation of ovulation". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
QKE
Device name
Immunoassay, Pregnanediol Glucuronide, Over The Counter
FDA definition
Over-the-counter detection of pregnanediol glucuronide for the confirmation of ovulation
Regulation
21 CFR 862.1620
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
1
Ingested recalls
0

Clearances, product code QKE

By decision year
1 clearance under product code QKE with a decision year between 2020 and 2020, 2020 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code QKE by decision year
YearClearances
20201

Applicants with the most clearances

Product code QKE
Applicants holding the most 510(k) clearances under product code QKE
ApplicantClearances
MFB Fertility, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 15 companies shown, in name order