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

System, Test, Osteocalcin

21 CFR 862.1050 / Clinical Chemistry
FDA source (opens on fda.gov)

NEO is the FDA product code for System, Test, Osteocalcin, a class II device type, regulated under 21 CFR 862.1050. As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and 2 recalls.

Classification record

Product code
NEO
Device name
System, Test, Osteocalcin
Regulation
21 CFR 862.1050
Device class
Class II
Review panel
Clinical Chemistry
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
2
Ingested recalls
2

Clearances, product code NEO

By decision year
2 clearances under product code NEO with a decision year between 2001 and 2005, 2001 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code NEO by decision year
YearClearances
20011
20051

Applicants with the most clearances

Product code NEO
Applicants holding the most 510(k) clearances under product code NEO
ApplicantClearances
Osteometer Biotech A/S1
Roche Diagnostics GmbH1

Companies listing this code with FDA

Companies whose registered establishments list this code