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FDA 510(k)

RAPIDONE-OXY TEST

K-Number: K014101 · 2002-03-20

ApplicantAmerican Bio Medica Corp.
Decision Date2002-03-20
Product CodeDJG
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

RAPIDONE-OXY 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 2002-03-20 under 510(k) number K014101. The device is classified under product code DJG. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RAPIDONE-OXY TEST?

RAPIDONE-OXY TEST is a medical device that received FDA 510(k) clearance on 2002-03-20. The listed applicant is American Bio Medica Corp.. The 510(k) number is K014101.

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

RAPIDONE-OXY TEST received FDA 510(k) clearance on 2002-03-20, under 510(k) number K014101.

Who is the listed applicant for RAPIDONE-OXY 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-OXY TEST?

The FDA product code for RAPIDONE-OXY TEST is DJG.

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Other records listing American Bio Medica Corp. as applicant

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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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