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FDA 510(k)

RAPIDONE- BARBITURATE TEST

K-Number: K992451 · 2000-04-03

ApplicantAmerican Bio Medica Corp.
Decision Date2000-04-03
Product CodeDIS
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

RAPIDONE- BARBITURATE 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 2000-04-03 under 510(k) number K992451. The device is classified under product code DIS. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RAPIDONE- BARBITURATE TEST?

RAPIDONE- BARBITURATE TEST is a medical device that received FDA 510(k) clearance on 2000-04-03. The listed applicant is American Bio Medica Corp.. The 510(k) number is K992451.

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

RAPIDONE- BARBITURATE TEST received FDA 510(k) clearance on 2000-04-03, under 510(k) number K992451.

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

The FDA product code for RAPIDONE- BARBITURATE TEST is DIS.

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Related Devices (Code: DIS)

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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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