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

Control, Fecal Occult Blood

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

OSL is the FDA product code for Control, Fecal Occult Blood, a class II device type, regulated under 21 CFR 864.6550. FDA's definition for this code reads: "Fecal occult blood controls (Negative and positive) are used to verify the performance of the fecal occult blood test devices". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
OSL
Device name
Control, Fecal Occult Blood
FDA definition
Fecal occult blood controls (Negative and positive) are used to verify the performance of the fecal occult blood test devices.
Regulation
21 CFR 864.6550
Device class
Class II
Review panel
Hematology
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
1
Ingested recalls
0

Clearances, product code OSL

By decision year
1 clearance under product code OSL with a decision year between 2010 and 2010, 2010 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code OSL by decision year
YearClearances
20101

Applicants with the most clearances

Product code OSL
Applicants holding the most 510(k) clearances under product code OSL
ApplicantClearances
Bionostics, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code