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

Reagent, Occult Blood

21 CFR 864.6550 / Hematology
FDA source (opens on fda.gov)

KHE is the FDA product code for Reagent, Occult Blood, a class II device type, regulated under 21 CFR 864.6550. As of , FDA records hold 97 510(k) clearances under this code, the most recent dated , and 19 recalls.

Classification record

Product code
KHE
Device name
Reagent, Occult Blood
Regulation
21 CFR 864.6550
Device class
Class II
Review panel
Hematology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
97
Ingested recalls
19

Clearances, product code KHE

By decision year
97 clearances under product code KHE with a decision year between 1976 and 2018, 1984 the highest year at 10.
Show the numbers
510(k) clearances under FDA product code KHE by decision year
YearClearances
19761
19771
19782
19802
19814
19825
19833
198410
19853
19866
19888
19891
19903
19914
19922
19951
19961
19971
19982
19992
20001
20013
20022
20033
20042
20051
20065
20073
20083
20102
20112
20122
20151
20174
20181

Applicants with the most clearances

Product code KHE
Applicants holding the most 510(k) clearances under product code KHE
ApplicantClearances
Helena Laboratories, Corp.12
Immunostics, Inc.7
Smithkline Diagnostics, Inc.4
Aerscher Diagnostics3
Alfa Scientific Designs, Inc.3
Enterix, Inc.3
Propper Mfg Co Inc3
Breit Laboratories, Inc.2
Cambridge Chemical Products, Inc.2
Gamma Biologicals, Inc.2

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 53 companies shown, in name order