FDA product code DMZ: Liquid Chromatography, Adsorbent

DMZ is the FDA product code for liquid chromatography, adsorbent. It is a Class I device, regulated under 21 CFR 862.2260 and reviewed by the Clinical Toxicology panel. FDA has cleared 1 510(k) submission under DMZ. The average 510(k) review took 36 days (median 36).

Classification

FieldValue
Device nameLiquid Chromatography, Adsorbent
Device classClass I
Regulation21 CFR 862.2260
Review panelTX — Clinical Toxicology
Medical specialtyClinical Chemistry
Premarket route510(k) exempt

Compare with all 510(k) review times · Search every DMZ clearance

Top DMZ applicants

ApplicantClearancesLatest
Hamilton Co.11983-08-12

Most recent DMZ clearances

510(k)ApplicantDeviceDecision dateReview days
K832197Hamilton Co.PRP-1 REVERSED PHASE RESIN1983-08-1236

Recalls for DMZ devices

openFDA lists no recalls for product code DMZ.

Frequently asked questions

What is FDA product code DMZ?

DMZ is the FDA product code for liquid chromatography, adsorbent. It is a Class I device, regulated under 21 CFR 862.2260 and reviewed by the Clinical Toxicology panel.

What device class is DMZ?

Class I, regulation 21 CFR 862.2260. Typical premarket route: 510(k) exempt.

How long does a 510(k) take for product code DMZ?

Across 1 cleared submissions the average was 36 days from receipt to decision (median 36).

Which companies have the most DMZ clearances?

Hamilton Co. (1).

Next steps

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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