FDA 510(k)

Rapid Tox Cup II

K-Number: K170222 · 2017-08-15

Decision Date2017-08-15

Product CodeLAF

Advisory CommitteeTX

DecisionSubstantially Equivalent

Device Summary

Rapid Tox Cup II is the device name listed in this FDA 510(k) record. The listed applicant is American Bio Medica Corp.. It received FDA 510(k) clearance on 2017-08-15 under 510(k) 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. The listed applicant is American Bio Medica Corp.. The 510(k) number is K170222.

When did Rapid Tox Cup II receive FDA 510(k) clearance?

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

Who is the listed applicant for Rapid Tox Cup II?

The FDA 510(k) record lists American Bio Medica Corp. as the applicant. This does not by itself establish the device manufacturer.

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.