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FDA 510(k)

MODIFICATION TO RAPID DRUG SCREEN 9-PANEL

K-Number: K002447 · 2000-11-16

ApplicantAmerican Bio Medica Corp.
Decision Date2000-11-16
Product CodeDKZ
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO RAPID DRUG SCREEN 9-PANEL 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 2000-11-16 under 510(k) number K002447. The device is classified under product code DKZ. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFICATION TO RAPID DRUG SCREEN 9-PANEL?

MODIFICATION TO RAPID DRUG SCREEN 9-PANEL is a medical device that received FDA 510(k) clearance on 2000-11-16. The listed applicant is American Bio Medica Corp.. The 510(k) number is K002447.

When did MODIFICATION TO RAPID DRUG SCREEN 9-PANEL receive FDA 510(k) clearance?

MODIFICATION TO RAPID DRUG SCREEN 9-PANEL received FDA 510(k) clearance on 2000-11-16, under 510(k) number K002447.

Who is the listed applicant for MODIFICATION TO RAPID DRUG SCREEN 9-PANEL?

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 MODIFICATION TO RAPID DRUG SCREEN 9-PANEL?

The FDA product code for MODIFICATION TO RAPID DRUG SCREEN 9-PANEL is DKZ.

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Related Devices (Code: DKZ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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