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FDA 510(k)

STC METHADONE INTERCEPT MICRO-PLATE EIA, MODEL 11421

K-Number: K002010 · 2000-11-29

ApplicantOraSure Technologies, Inc.
Decision Date2000-11-29
Product CodeDJR
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

STC METHADONE INTERCEPT MICRO-PLATE EIA, MODEL 11421 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 2000-11-29 under 510(k) number K002010. The device is classified under product code DJR. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STC METHADONE INTERCEPT MICRO-PLATE EIA, MODEL 11421?

STC METHADONE INTERCEPT MICRO-PLATE EIA, MODEL 11421 is a medical device that received FDA 510(k) clearance on 2000-11-29. The listed applicant is OraSure Technologies, Inc.. The 510(k) number is K002010.

When did STC METHADONE INTERCEPT MICRO-PLATE EIA, MODEL 11421 receive FDA 510(k) clearance?

STC METHADONE INTERCEPT MICRO-PLATE EIA, MODEL 11421 received FDA 510(k) clearance on 2000-11-29, under 510(k) number K002010.

Who is the listed applicant for STC METHADONE INTERCEPT MICRO-PLATE EIA, MODEL 11421?

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 METHADONE INTERCEPT MICRO-PLATE EIA, MODEL 11421?

The FDA product code for STC METHADONE INTERCEPT MICRO-PLATE EIA, MODEL 11421 is DJR.

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Other records listing OraSure Technologies, Inc. as applicant

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Related Devices (Code: DJR)

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.

K192433LZI Methadone II Enzyme ImmunoassayLin-Zhi International, Inc.K182779ARK EDDP AssayArk Diagnostics, Inc.K170416LZI Methadone Metabolite Enzyme Immunoassay, LZI Methadone Metabolite (100 and 300) CalibratorsLin-Zhi International, Inc.K160793First Sign Drug of Abuse Dip Card Test (MDMA, EDDP, Nortriptyline), First Sign Drug of Abuse Cup Test (MDMA, EDDP, Nortriptyline)W.H.P.M., Inc.K131232WONDFO METHADONE URINE TEST (MTD 200), WONDOFO MORPHINE URINE TEST (MOP 100)Guangzhou Wondfo Biotech Co., Ltd.K092272RANDOX METHADONE ASSAYRandox Laboratories, Ltd.

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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