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

Blood, Occult, Colorimetric, In Urine

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

JIO is the FDA product code for Blood, Occult, Colorimetric, In Urine, a class II device type, regulated under 21 CFR 864.6550. As of , FDA records hold 11 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
JIO
Device name
Blood, Occult, Colorimetric, In Urine
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
11
Ingested recalls
0

Clearances, product code JIO

By decision year
11 clearances under product code JIO with a decision year between 1989 and 2024, 1991 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code JIO by decision year
YearClearances
19891
19912
19921
20031
20041
20092
20122
20241

Applicants with the most clearances

Product code JIO
Applicants holding the most 510(k) clearances under product code JIO
ApplicantClearances
URIT Medical Electronic Co., Ltd.2
Acon Laboratories, Inc.1
Dirui Industrial Co., Ltd.1
Healgen Scientific LLC1
Kulzer GmbH1
Lee Import Domestic Consulting1
Remel Inc1
Symcon Intl., Inc.1
Teco Diagnostics1
Wiener Laboratorios S.A.I.C.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 43 companies shown, in name order