FDA product code NWZ: Gas Chromatography, Bacillus Anthracis Membrane Fatty Acids
NWZ is the FDA product code for gas chromatography, bacillus anthracis membrane fatty acids. It is a Class II device, regulated under 21 CFR 866.3045 and reviewed by the Microbiology panel. FDA has cleared 1 510(k) submission under NWZ. The average 510(k) review took 130 days (median 130).
Definition
Aid in the identification of Bacillus Anthracis
Classification
| Field | Value |
|---|---|
| Device name | Gas Chromatography, Bacillus Anthracis Membrane Fatty Acids |
| Device class | Class II |
| Regulation | 21 CFR 866.3045 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) |
Compare with all 510(k) review times · Search every NWZ clearance
Top NWZ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Midi, Inc. | 1 | 2006-01-17 |
Most recent NWZ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K052485 | Midi, Inc. | SHERLOCK MICROBIAL IDENTIFICATION SYSTEM FOR BIODEF | 2006-01-17 | 130 |
Recalls for NWZ devices
openFDA lists no recalls for product code NWZ.
Frequently asked questions
What is FDA product code NWZ?
NWZ is the FDA product code for gas chromatography, bacillus anthracis membrane fatty acids. It is a Class II device, regulated under 21 CFR 866.3045 and reviewed by the Microbiology panel.
What device class is NWZ?
Class II, regulation 21 CFR 866.3045. Typical premarket route: 510(k).
How long does a 510(k) take for product code NWZ?
Across 1 cleared submissions the average was 130 days from receipt to decision (median 130).
Which companies have the most NWZ clearances?
Midi, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code NWZ
- Run a recall and safety report across every NWZ manufacturer
- Watch product code NWZ for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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