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FDA 510(k)

RAPID DRUG SCREEN

K-Number: K964900 · 1997-04-14

ApplicantAmerican Bio Medica Corp.
Decision Date1997-04-14
Product CodeDIO
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

RAPID DRUG SCREEN 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 1997-04-14 under 510(k) number K964900. The device is classified under product code DIO. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RAPID DRUG SCREEN?

RAPID DRUG SCREEN is a medical device that received FDA 510(k) clearance on 1997-04-14. The listed applicant is American Bio Medica Corp.. The 510(k) number is K964900.

When did RAPID DRUG SCREEN receive FDA 510(k) clearance?

RAPID DRUG SCREEN received FDA 510(k) clearance on 1997-04-14, under 510(k) number K964900.

Who is the listed applicant for RAPID DRUG SCREEN?

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 DRUG SCREEN?

The FDA product code for RAPID DRUG SCREEN is DIO.

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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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