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FDA 510(k)

'RAPID DRUG SCREEN' 8 PANEL-LOW VOLUME

K-Number: K981705 · 1998-08-27

ApplicantAmerican Bio Medica Corp.
Decision Date1998-08-27
Product CodeDKZ
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

'RAPID DRUG SCREEN' 8 PANEL-LOW VOLUME 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 1998-08-27 under 510(k) number K981705. 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 'RAPID DRUG SCREEN' 8 PANEL-LOW VOLUME?

'RAPID DRUG SCREEN' 8 PANEL-LOW VOLUME is a medical device that received FDA 510(k) clearance on 1998-08-27. The listed applicant is American Bio Medica Corp.. The 510(k) number is K981705.

When did 'RAPID DRUG SCREEN' 8 PANEL-LOW VOLUME receive FDA 510(k) clearance?

'RAPID DRUG SCREEN' 8 PANEL-LOW VOLUME received FDA 510(k) clearance on 1998-08-27, under 510(k) number K981705.

Who is the listed applicant for 'RAPID DRUG SCREEN' 8 PANEL-LOW VOLUME?

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' 8 PANEL-LOW VOLUME?

The FDA product code for 'RAPID DRUG SCREEN' 8 PANEL-LOW VOLUME is DKZ.

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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.

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