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

Calibrator For Hemoglobin And Hematocrit Measurement

21 CFR 864.8165 / Hematology
FDA source (opens on fda.gov)

KRZ is the FDA product code for Calibrator For Hemoglobin And Hematocrit Measurement, a class II device type, regulated under 21 CFR 864.8165. As of , FDA records hold 25 510(k) clearances under this code, the most recent dated , and 2 recalls.

Classification record

Product code
KRZ
Device name
Calibrator For Hemoglobin And Hematocrit Measurement
Regulation
21 CFR 864.8165
Device class
Class II
Review panel
Hematology
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
25
Ingested recalls
2

Clearances, product code KRZ

By decision year
25 clearances under product code KRZ with a decision year between 1979 and 2005, 1988 the highest year at 4.
Show the numbers
510(k) clearances under FDA product code KRZ by decision year
YearClearances
19791
19801
19822
19833
19843
19851
19861
19872
19884
19891
19902
19951
19961
20041
20051

Applicants with the most clearances

Product code KRZ
Applicants holding the most 510(k) clearances under product code KRZ
ApplicantClearances
Medical Specialties Inc.3
Alko Diagnostic Corp.2
American Dade1
BD Becton Dickinson Vacutainer Systems Preanalytic1
Biodiagnostic Intl1
Bionostics, Inc.1
Clinical Diagnostic Solutions, Inc.1
Helena Laboratories, Corp.1
Hematology Marketing Assoc.1
In Vitro Diagnostics, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 15 companies shown, in name order