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

Calibrator For Cell Indices

21 CFR 864.8150 / Hematology
FDA source (opens on fda.gov)

KRX is the FDA product code for Calibrator For Cell Indices, a class II device type, regulated under 21 CFR 864.8150. As of , FDA records hold 16 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
KRX
Device name
Calibrator For Cell Indices
Regulation
21 CFR 864.8150
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
16
Ingested recalls
0

Clearances, product code KRX

By decision year
16 clearances under product code KRX with a decision year between 1981 and 2016, 1981 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code KRX by decision year
YearClearances
19812
19831
19861
19911
19961
19991
20011
20021
20091
20111
20122
20142
20161

Applicants with the most clearances

Product code KRX
Applicants holding the most 510(k) clearances under product code KRX
ApplicantClearances
Streck LLC7
R & D Systems, Inc.4
Streck Laboratories, Inc.2
American Dade1
Clinical Diagnostic Solutions, Inc.1
Diagnostic Technology, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 14 companies shown, in name order