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FDA 510(k)

AXSYM METHADONE

K-Number: K953499 · 1995-11-13

ApplicantAbbott Laboratories
Decision Date1995-11-13
Product CodeDJR
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

AXSYM METHADONE is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 1995-11-13 under 510(k) number K953499. 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 AXSYM METHADONE?

AXSYM METHADONE is a medical device that received FDA 510(k) clearance on 1995-11-13. The listed applicant is Abbott Laboratories. The 510(k) number is K953499.

When did AXSYM METHADONE receive FDA 510(k) clearance?

AXSYM METHADONE received FDA 510(k) clearance on 1995-11-13, under 510(k) number K953499.

Who is the listed applicant for AXSYM METHADONE?

The FDA 510(k) record lists Abbott Laboratories as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AXSYM METHADONE?

The FDA product code for AXSYM METHADONE is DJR.

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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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