FDA product code GHC: Tube, Sedimentation Rate

GHC is the FDA product code for tube, sedimentation rate. It is a Class I device, regulated under 21 CFR 864.6700 and reviewed by the Hematology panel. FDA has cleared 1 510(k) submission under GHC. The average 510(k) review took 246 days (median 246). FDA has posted 1 recall for GHC devices.

Classification

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

Top GHC applicants

Most recent GHC clearances

Recalls for GHC devices

1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2010-04-12.

Frequently asked questions

What is FDA product code GHC?

GHC is the FDA product code for tube, sedimentation rate. It is a Class I device, regulated under 21 CFR 864.6700 and reviewed by the Hematology panel.

What device class is GHC?

Class I, regulation 21 CFR 864.6700. Typical premarket route: 510(k) exempt.

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

Across 1 cleared submissions the average was 246 days from receipt to decision (median 246).

Which companies have the most GHC clearances?

Investigacion Farmaceutica S.A. DE C.V. (1).

Have GHC devices been recalled?

Yes: 1 product recalls across 1 recall events; the most recent began 2010-04-12.

Next steps

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