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

Red-Cell Indices

21 CFR 864.5300 / Hematology
FDA source (opens on fda.gov)

KQH is the FDA product code for Red-Cell Indices, a class II device type, regulated under 21 CFR 864.5300. As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
KQH
Device name
Red-Cell Indices
Regulation
21 CFR 864.5300
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 KQH

By decision year
1 clearance under product code KQH with a decision year between 1986 and 1986, 1986 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code KQH by decision year
YearClearances
19861

Applicants with the most clearances

Product code KQH
Applicants holding the most 510(k) clearances under product code KQH
ApplicantClearances
V.Marc, A Div. of Pictorial, 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 KQH.