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

Assay, Porphyrin, Spectrophotometry, Lithium

21 CFR 862.3560 / Clinical Toxicology
FDA source (opens on fda.gov)

NDW is the FDA product code for Assay, Porphyrin, Spectrophotometry, Lithium, a class II device type, regulated under 21 CFR 862.3560. As of , FDA records hold 7 510(k) clearances under this code, the most recent dated , and 7 recalls.

Classification record

Product code
NDW
Device name
Assay, Porphyrin, Spectrophotometry, Lithium
Regulation
21 CFR 862.3560
Device class
Class II
Review panel
Clinical Toxicology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
7
Ingested recalls
7

Clearances, product code NDW

By decision year
7 clearances under product code NDW with a decision year between 2001 and 2025, 2007 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code NDW by decision year
YearClearances
20011
20051
20072
20081
20111
20251

Applicants with the most clearances

Product code NDW
Applicants holding the most 510(k) clearances under product code NDW
ApplicantClearances
Medrad, Inc.1
Diazyme Laboratories, Inc.1
Roche Diagnostics GmbH1
Sentinel CH SpA1
Siemens Healthcare Diagnostics Inc.1
Thermo Electron Oy1
Trace America, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code