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

Fluorometer, For Clinical Use

21 CFR 862.2560 / Clinical Chemistry
FDA source (opens on fda.gov)

KHO is the FDA product code for Fluorometer, For Clinical Use, a class I device type, regulated under 21 CFR 862.2560. As of , FDA records hold 38 510(k) clearances under this code, the most recent dated , and 32 recalls.

Classification record

Product code
KHO
Device name
Fluorometer, For Clinical Use
Regulation
21 CFR 862.2560
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
38
Ingested recalls
32

Clearances, product code KHO

By decision year
38 clearances under product code KHO with a decision year between 1976 and 2012, 1978 the highest year at 4.
Show the numbers
510(k) clearances under FDA product code KHO by decision year
YearClearances
19762
19784
19793
19801
19813
19824
19831
19851
19861
19872
19893
19901
19911
19922
19932
19941
19952
19961
19971
19981
20121

Applicants with the most clearances

Product code KHO
Applicants holding the most 510(k) clearances under product code KHO
ApplicantClearances
Revvity Health Sciences, Inc.5
Abbott Medical2
Baxter Healthcare Corporation2
Lkb Instruments, Inc.2
Miles Laboratories, Inc.2
Pb Diagnostic Systems, Inc.2
Tosoh Corp.2
Abbott Diagnostics1
American Diagnostic Corp.1
Bio-Chem Laboratory Systems, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 41 companies shown, in name order