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

Red-Cell Count By Photometry

21 CFR 864.7100 / Hematology
FDA source (opens on fda.gov)

LKZ is the FDA product code for Red-Cell Count By Photometry, a class II device type, regulated under 21 CFR 864.7100. As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
LKZ
Device name
Red-Cell Count By Photometry
Regulation
21 CFR 864.7100
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
2
Ingested recalls
0

Clearances, product code LKZ

By decision year
2 clearances under product code LKZ with a decision year between 1983 and 1984, 1983 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code LKZ by decision year
YearClearances
19831
19841

Applicants with the most clearances

Product code LKZ
Applicants holding the most 510(k) clearances under product code LKZ
ApplicantClearances
Bio-Analytics Laboratories, Inc.1
Worthington Diagnostic Systems1

Companies listing this code with FDA

Companies whose registered establishments list this code

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