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FDA 510(k)

AUTO-LYTE COCAINE METABOLITE EIA, MODEL # 1222U

K-Number: K982759 · 1998-11-20

ApplicantOraSure Technologies, Inc.
Decision Date1998-11-20
Product CodeDIO
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

AUTO-LYTE COCAINE METABOLITE EIA, MODEL # 1222U is the device name listed in this FDA 510(k) record. The listed applicant is OraSure Technologies, Inc.. It received FDA 510(k) clearance on 1998-11-20 under 510(k) number K982759. The device is classified under product code DIO. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AUTO-LYTE COCAINE METABOLITE EIA, MODEL # 1222U?

AUTO-LYTE COCAINE METABOLITE EIA, MODEL # 1222U is a medical device that received FDA 510(k) clearance on 1998-11-20. The listed applicant is OraSure Technologies, Inc.. The 510(k) number is K982759.

When did AUTO-LYTE COCAINE METABOLITE EIA, MODEL # 1222U receive FDA 510(k) clearance?

AUTO-LYTE COCAINE METABOLITE EIA, MODEL # 1222U received FDA 510(k) clearance on 1998-11-20, under 510(k) number K982759.

Who is the listed applicant for AUTO-LYTE COCAINE METABOLITE EIA, MODEL # 1222U?

The FDA 510(k) record lists OraSure Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AUTO-LYTE COCAINE METABOLITE EIA, MODEL # 1222U?

The FDA product code for AUTO-LYTE COCAINE METABOLITE EIA, MODEL # 1222U is DIO.

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Related Devices (Code: DIO)

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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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