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

Antibodies, Saccharomyces Cerevisiae (S.Cerevisiae)

21 CFR 866.5785 / Immunology
FDA source (opens on fda.gov)

NBT is the FDA product code for Antibodies, Saccharomyces Cerevisiae (S.Cerevisiae), a class II device type, regulated under 21 CFR 866.5785. As of , FDA records hold 8 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
NBT
Device name
Antibodies, Saccharomyces Cerevisiae (S.Cerevisiae)
Regulation
21 CFR 866.5785
Device class
Class II
Review panel
Immunology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
8
Ingested recalls
0

Clearances, product code NBT

By decision year
8 clearances under product code NBT with a decision year between 2000 and 2007, 2004 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code NBT by decision year
YearClearances
20001
20011
20042
20052
20061
20071

Applicants with the most clearances

Product code NBT
Applicants holding the most 510(k) clearances under product code NBT
ApplicantClearances
Immco Diagnostics, Inc.2
Inova Diagnostics, Inc.2
Aesku, Inc.1
Techlab Inc., Corporate Research Center1
Techlab, Inc.1
The Binding Site1

Companies listing this code with FDA

Companies whose registered establishments list this code