FDA product code IBM: Microscope, Phase Contrast

IBM is the FDA product code for microscope, phase contrast. It is a Class I device, regulated under 21 CFR 864.3600 and reviewed by the Pathology panel. FDA has cleared 1 510(k) submission under IBM. The average 510(k) review took 183 days (median 183). FDA has posted 1 recall for IBM devices.

Classification

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Recalls for IBM devices

1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2013-02-22.

Frequently asked questions

What is FDA product code IBM?

IBM is the FDA product code for microscope, phase contrast. It is a Class I device, regulated under 21 CFR 864.3600 and reviewed by the Pathology panel.

What device class is IBM?

Class I, regulation 21 CFR 864.3600. Typical premarket route: 510(k) exempt.

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

Across 1 cleared submissions the average was 183 days from receipt to decision (median 183).

Which companies have the most IBM clearances?

Technalysis, Inc. (1).

Have IBM devices been recalled?

Yes: 1 product recalls across 1 recall events; the most recent began 2013-02-22.

Next steps

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