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FDA 510(k)

Rapid Tox Cup II

K-Number: K170222 · 2017-08-15

ApplicantAmerican Bio Medica Corp.
Decision Date2017-08-15
Product CodeLAF
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

Rapid Tox Cup II is a medical device manufactured by American Bio Medica Corp.. It received FDA 510(k) clearance on 2017-08-15 under approval number K170222. The device is classified under product code LAF. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Rapid Tox Cup II?

Rapid Tox Cup II is a medical device that received FDA 510(k) clearance on 2017-08-15. It is manufactured by American Bio Medica Corp.. The 510(k) number is K170222.

When was Rapid Tox Cup II approved by the FDA?

Rapid Tox Cup II received FDA 510(k) clearance on 2017-08-15, under approval number K170222.

What company makes Rapid Tox Cup II?

Rapid Tox Cup II is manufactured by American Bio Medica Corp..

What is the FDA product code for Rapid Tox Cup II?

The FDA product code for Rapid Tox Cup II is LAF.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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