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FDA 510(k)

RAPIDONE-ECSTASY TEST

K-Number: K013180 · 2001-11-26

ApplicantAmerican Bio Medica Corp.
Decision Date2001-11-26
Product CodeDJC
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

RAPIDONE-ECSTASY TEST 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 2001-11-26 under 510(k) number K013180. The device is classified under product code DJC. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RAPIDONE-ECSTASY TEST?

RAPIDONE-ECSTASY TEST is a medical device that received FDA 510(k) clearance on 2001-11-26. The listed applicant is American Bio Medica Corp.. The 510(k) number is K013180.

When did RAPIDONE-ECSTASY TEST receive FDA 510(k) clearance?

RAPIDONE-ECSTASY TEST received FDA 510(k) clearance on 2001-11-26, under 510(k) number K013180.

Who is the listed applicant for RAPIDONE-ECSTASY TEST?

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 RAPIDONE-ECSTASY TEST?

The FDA product code for RAPIDONE-ECSTASY TEST is DJC.

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Official Source

View on FDA Database →

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

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