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FDA 510(k)

RAPIDONE- BENZODIAZEPINE TEST

K-Number: K992720 · 2000-04-03

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

Device Summary

RAPIDONE- BENZODIAZEPINE 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 K992720. The device is classified under product code JXM. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RAPIDONE- BENZODIAZEPINE TEST?

RAPIDONE- BENZODIAZEPINE 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 K992720.

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

RAPIDONE- BENZODIAZEPINE TEST received FDA 510(k) clearance on 2000-04-03, under 510(k) number K992720.

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

The FDA product code for RAPIDONE- BENZODIAZEPINE TEST is JXM.

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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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