FDA product code GJH: Stain, Reticulocyte

GJH is the FDA product code for stain, reticulocyte. It is a Class I device, regulated under 21 CFR 864.1850 and reviewed by the Hematology panel. FDA has cleared 1 510(k) submission under GJH. The average 510(k) review took 41 days (median 41). FDA has posted 1 recall for GJH devices.

Classification

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

Top GJH applicants

Most recent GJH clearances

Recalls for GJH devices

1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2004-06-24.

Frequently asked questions

What is FDA product code GJH?

GJH is the FDA product code for stain, reticulocyte. It is a Class I device, regulated under 21 CFR 864.1850 and reviewed by the Hematology panel.

What device class is GJH?

Class I, regulation 21 CFR 864.1850. Typical premarket route: 510(k) exempt.

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

Across 1 cleared submissions the average was 41 days from receipt to decision (median 41).

Which companies have the most GJH clearances?

Geometric Data, Div. Smithkline Corp. (1).

Have GJH devices been recalled?

Yes: 1 product recalls across 1 recall events; the most recent began 2004-06-24.

Next steps

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