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FDA 510(k)

RAPID READER

K-Number: K041696 · 2005-07-12

ApplicantAmerican Bio Medica Corp.
Decision Date2005-07-12
Product CodeDKZ
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

RAPID READER 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 2005-07-12 under 510(k) number K041696. 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 READER?

RAPID READER is a medical device that received FDA 510(k) clearance on 2005-07-12. The listed applicant is American Bio Medica Corp.. The 510(k) number is K041696.

When did RAPID READER receive FDA 510(k) clearance?

RAPID READER received FDA 510(k) clearance on 2005-07-12, under 510(k) number K041696.

Who is the listed applicant for RAPID READER?

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 READER?

The FDA product code for RAPID READER is DKZ.

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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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