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

System, Test, Blood Glucose, Over The Counter

21 CFR 862.1345 / Clinical Chemistry
FDA source (opens on fda.gov)

NBW is the FDA product code for System, Test, Blood Glucose, Over The Counter, a class II device type, regulated under 21 CFR 862.1345. As of , FDA records hold 510 510(k) clearances under this code, the most recent dated , and 137 recalls.

Classification record

Product code
NBW
Device name
System, Test, Blood Glucose, Over The Counter
Regulation
21 CFR 862.1345
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
No
Ingested clearances
510
Ingested recalls
137

Clearances, product code NBW

By decision year
510 clearances under product code NBW with a decision year between 2001 and 2026, 2013 the highest year at 47.
Show the numbers
510(k) clearances under FDA product code NBW by decision year
YearClearances
200112
200217
200311
200413
200516
200627
200729
200837
200938
201031
201130
201230
201347
201424
201532
201620
201725
201819
201910
20207
20217
202212
20235
20247
20252
20262

Applicants with the most clearances

Product code NBW
Applicants holding the most 510(k) clearances under product code NBW
ApplicantClearances
Taidoc Technology Corporation65
Abbott Medical31
I-SENS, Inc.21
Roche Diagnostics GmbH20
Apex Biotechnology Corp.18
Bionime Corporation18
Medrad, Inc.17
Infopia Co, Ltd.15
Agamatrix14
Eps Bio Technology Corp.14

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 164 companies shown, in name order