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

Chromatography (Liquid, Gel), Clinical Use

21 CFR 862.2260 / Clinical Chemistry
FDA source (opens on fda.gov)

KZR is the FDA product code for Chromatography (Liquid, Gel), Clinical Use, a class I device type, regulated under 21 CFR 862.2260. As of , FDA records hold 15 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
KZR
Device name
Chromatography (Liquid, Gel), Clinical Use
Regulation
21 CFR 862.2260
Device class
Class I
Review panel
Clinical Chemistry
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
15
Ingested recalls
0

Clearances, product code KZR

By decision year
15 clearances under product code KZR with a decision year between 1977 and 1997, 1984 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code KZR by decision year
YearClearances
19772
19782
19801
19831
19843
19851
19862
19911
19931
19971

Applicants with the most clearances

Product code KZR
Applicants holding the most 510(k) clearances under product code KZR
ApplicantClearances
Revvity Health Sciences, Inc.5
Varian Assoc., Inc.3
E.I. Dupont de Nemours & Co., Inc.2
Hamilton Co1
Millpore Corp.1
Syva Co.1
U.S. Drug Testing, Inc.1
Waters Corporation1

Companies listing this code with FDA

Companies whose registered establishments list this code