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

Apparatus, High Pressure Liquid Chromatography

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

KIE is the FDA product code for Apparatus, High Pressure Liquid Chromatography, a class I device type, regulated under 21 CFR 862.2260. As of , FDA records hold 25 510(k) clearances under this code, the most recent dated , and 2 recalls.

Classification record

Product code
KIE
Device name
Apparatus, High Pressure Liquid Chromatography
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
25
Ingested recalls
2

Clearances, product code KIE

By decision year
25 clearances under product code KIE with a decision year between 1977 and 1996, 1980 the highest year at 6.
Show the numbers
510(k) clearances under FDA product code KIE by decision year
YearClearances
19774
19783
19794
19806
19852
19861
19912
19921
19941
19961

Applicants with the most clearances

Product code KIE
Applicants holding the most 510(k) clearances under product code KIE
ApplicantClearances
Hewlett-Packard Co.4
Laboratory Data Control4
Waters Assoc., Inc.4
EMD Millipore Corporation3
Revvity Health Sciences, Inc.3
Syva Co.2
E.I. Dupont de Nemours & Co., Inc.1
Peokin-Elmer Corp.1
Rohm and Haas Co.1
Varian Assoc., Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code