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

Automated Occult Blood Analyzer

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

OOX is the FDA product code for Automated Occult Blood Analyzer, a class II device type, regulated under 21 CFR 864.6550. FDA's definition for this code reads: "The automated test system is intended for the qualitative detection of fecal occult blood in feces by professional laboratories. The automated test is used for the determination of gastrointestinal bleeding". As of , FDA records hold 6 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
OOX
Device name
Automated Occult Blood Analyzer
FDA definition
The automated test system is intended for the qualitative detection of fecal occult blood in feces by professional laboratories. The automated test is used for the determination of gastrointestinal bleeding.
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
6
Ingested recalls
0

Clearances, product code OOX

By decision year
6 clearances under product code OOX with a decision year between 2004 and 2022, 2004 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code OOX by decision year
YearClearances
20041
20101
20141
20171
20201
20221

Applicants with the most clearances

Product code OOX
Applicants holding the most 510(k) clearances under product code OOX
ApplicantClearances
Boditech Med Inc.1
Eiken Chemical Co., Ltd.1
Immunostics, Inc.1
Polymedco Cancer Diagnostics, LLC1
Polymedco, Inc.,/Polymedco Cancer Diagnostic Products, LLC1
WHPM Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 16 companies shown, in name order