510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
KQEClass II

Assay, Erythrocytic Glucose-6-Phosphate Dehydrogenase

21 CFR 864.7360 / Hematology
FDA source (opens on fda.gov)

KQE is the FDA product code for Assay, Erythrocytic Glucose-6-Phosphate Dehydrogenase, a class II device type, regulated under 21 CFR 864.7360. As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
KQE
Device name
Assay, Erythrocytic Glucose-6-Phosphate Dehydrogenase
Regulation
21 CFR 864.7360
Device class
Class II
Review panel
Hematology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
1
Ingested recalls
0

Clearances, product code KQE

By decision year
1 clearance under product code KQE with a decision year between 1983 and 1983, 1983 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code KQE by decision year
YearClearances
19831

Applicants with the most clearances

Product code KQE
Applicants holding the most 510(k) clearances under product code KQE
ApplicantClearances
Alladin Diagnostic, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code KQE.