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FDA 510(k)

COCAINE METABOLITE INTERCEPT MICRO-PLATE EIA

K-Number: K001197 · 2000-05-11

ApplicantOraSure Technologies, Inc.
Decision Date2000-05-11
Product CodeDIO
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

COCAINE METABOLITE INTERCEPT MICRO-PLATE EIA 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 2000-05-11 under 510(k) number K001197. 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 COCAINE METABOLITE INTERCEPT MICRO-PLATE EIA?

COCAINE METABOLITE INTERCEPT MICRO-PLATE EIA is a medical device that received FDA 510(k) clearance on 2000-05-11. The listed applicant is OraSure Technologies, Inc.. The 510(k) number is K001197.

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

COCAINE METABOLITE INTERCEPT MICRO-PLATE EIA received FDA 510(k) clearance on 2000-05-11, under 510(k) number K001197.

Who is the listed applicant for COCAINE METABOLITE INTERCEPT MICRO-PLATE EIA?

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 COCAINE METABOLITE INTERCEPT MICRO-PLATE EIA?

The FDA product code for COCAINE METABOLITE INTERCEPT MICRO-PLATE EIA 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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