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FDA 510(k)

STC COCAINE METABOLITE MICRO-PLATE EIA (ORASURE DEVICE)

K-Number: K982061 · 1998-08-25

ApplicantOraSure Technologies, Inc.
Decision Date1998-08-25
Product CodeDIO
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

STC COCAINE METABOLITE MICRO-PLATE EIA (ORASURE DEVICE) 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 1998-08-25 under 510(k) number K982061. 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 STC COCAINE METABOLITE MICRO-PLATE EIA (ORASURE DEVICE)?

STC COCAINE METABOLITE MICRO-PLATE EIA (ORASURE DEVICE) is a medical device that received FDA 510(k) clearance on 1998-08-25. The listed applicant is OraSure Technologies, Inc.. The 510(k) number is K982061.

When did STC COCAINE METABOLITE MICRO-PLATE EIA (ORASURE DEVICE) receive FDA 510(k) clearance?

STC COCAINE METABOLITE MICRO-PLATE EIA (ORASURE DEVICE) received FDA 510(k) clearance on 1998-08-25, under 510(k) number K982061.

Who is the listed applicant for STC COCAINE METABOLITE MICRO-PLATE EIA (ORASURE DEVICE)?

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 STC COCAINE METABOLITE MICRO-PLATE EIA (ORASURE DEVICE)?

The FDA product code for STC COCAINE METABOLITE MICRO-PLATE EIA (ORASURE DEVICE) is DIO.

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Related Devices (Code: DIO)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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