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

Osmolality Of Tears

21 CFR 862.1540 / Clinical Chemistry
FDA source (opens on fda.gov)

OND is the FDA product code for Osmolality Of Tears, a class I device type, regulated under 21 CFR 862.1540. FDA's definition for this code reads: "To measure the osmolality of human tears to aid in the diagnosis of patients with signs or symptoms of dry eye disease, in conjunction with other methods of clinical evaluation". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
OND
Device name
Osmolality Of Tears
FDA definition
To measure the osmolality of human tears to aid in the diagnosis of patients with signs or symptoms of dry eye disease, in conjunction with other methods of clinical evaluation.
Regulation
21 CFR 862.1540
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
1
Ingested recalls
0

Clearances, product code OND

By decision year
1 clearance under product code OND with a decision year between 2009 and 2009, 2009 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code OND by decision year
YearClearances
20091

Applicants with the most clearances

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

Companies listing this code with FDA

Companies whose registered establishments list this code