FDA product code GHQ: Stain, Fetal Hemoglobin

GHQ is the FDA product code for stain, fetal hemoglobin. It is a Class II device, regulated under 21 CFR 864.7455 and reviewed by the Hematology panel. FDA has cleared 2 510(k) submissions under GHQ, from 2 different applicants. The average 510(k) review took 130 days (median 130). FDA has posted 1 recall for GHQ devices.

Classification

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

Top GHQ applicants

Most recent GHQ clearances

Recalls for GHQ devices

1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2018-02-07.

Frequently asked questions

What is FDA product code GHQ?

GHQ is the FDA product code for stain, fetal hemoglobin. It is a Class II device, regulated under 21 CFR 864.7455 and reviewed by the Hematology panel.

What device class is GHQ?

Class II, regulation 21 CFR 864.7455. Typical premarket route: 510(k) exempt.

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

Across 2 cleared submissions the average was 130 days from receipt to decision (median 130).

Which companies have the most GHQ clearances?

Caltag Laboratories, Inc. (1); Sure-Tech Diagnostic Associates, Inc. (1).

Have GHQ devices been recalled?

Yes: 1 product recalls across 1 recall events; the most recent began 2018-02-07.

Next steps

• Run an FDA pathway report with predicate devices for product code GHQ
• Run a recall and safety report across every GHQ manufacturer
• Watch product code GHQ 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.

All Hematology product codes · FDA product code lookup · 510(k) database search · 510(k) review times