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FDA 510(k)

EMIT II PLUS METHADONE ASSAY, MODEL OSRE229

K-Number: K010962 · 2001-04-26

ApplicantSyva Co., Dade Behring, Inc.
Decision Date2001-04-26
Product CodeDJR
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

EMIT II PLUS METHADONE ASSAY, MODEL OSRE229 is the device name listed in this FDA 510(k) record. The listed applicant is Syva Co., Dade Behring, Inc.. It received FDA 510(k) clearance on 2001-04-26 under 510(k) number K010962. 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 EMIT II PLUS METHADONE ASSAY, MODEL OSRE229?

EMIT II PLUS METHADONE ASSAY, MODEL OSRE229 is a medical device that received FDA 510(k) clearance on 2001-04-26. The listed applicant is Syva Co., Dade Behring, Inc.. The 510(k) number is K010962.

When did EMIT II PLUS METHADONE ASSAY, MODEL OSRE229 receive FDA 510(k) clearance?

EMIT II PLUS METHADONE ASSAY, MODEL OSRE229 received FDA 510(k) clearance on 2001-04-26, under 510(k) number K010962.

Who is the listed applicant for EMIT II PLUS METHADONE ASSAY, MODEL OSRE229?

The FDA 510(k) record lists Syva Co., Dade Behring, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EMIT II PLUS METHADONE ASSAY, MODEL OSRE229?

The FDA product code for EMIT II PLUS METHADONE ASSAY, MODEL OSRE229 is DJR.

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Other records listing Syva Co., Dade Behring, 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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