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

System, Test, Biotinidase

21 CFR 862.1118 / Clinical Chemistry
FDA source (opens on fda.gov)

NAK is the FDA product code for System, Test, Biotinidase, a class II device type, regulated under 21 CFR 862.1118. As of , FDA records hold 5 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
NAK
Device name
System, Test, Biotinidase
Regulation
21 CFR 862.1118
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
5
Ingested recalls
0

Clearances, product code NAK

By decision year
5 clearances under product code NAK with a decision year between 2000 and 2013, 2000 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code NAK by decision year
YearClearances
20001
20011
20081
20101
20131

Applicants with the most clearances

Product code NAK
Applicants holding the most 510(k) clearances under product code NAK
ApplicantClearances
Astoria-Pacific, Inc.2
Wallac Oy2
Revvity Health Sciences, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code