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

Assay, Fetal Hemoglobin

21 CFR 864.7455 / Hematology
FDA source (opens on fda.gov)

KQI is the FDA product code for Assay, Fetal Hemoglobin, a class II device type, regulated under 21 CFR 864.7455. As of , FDA records hold 4 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
KQI
Device name
Assay, Fetal Hemoglobin
Regulation
21 CFR 864.7455
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
4
Ingested recalls
0

Clearances, product code KQI

By decision year
4 clearances under product code KQI with a decision year between 1979 and 1988, 1981 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code KQI by decision year
YearClearances
19791
19812
19881

Applicants with the most clearances

Product code KQI
Applicants holding the most 510(k) clearances under product code KQI
ApplicantClearances
Helena Laboratories, Corp.3
Isolab, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code