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FDA 510(k)

VISUALINE II (ALSO KNOWN AS SUNLINE) METHADONE

K-Number: K981314 · 1998-09-04

ApplicantSun Biomedical Laboratories, Inc.
Decision Date1998-09-04
Product CodeDJR
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

VISUALINE II (ALSO KNOWN AS SUNLINE) METHADONE is the device name listed in this FDA 510(k) record. The listed applicant is Sun Biomedical Laboratories, Inc.. It received FDA 510(k) clearance on 1998-09-04 under 510(k) number K981314. 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 VISUALINE II (ALSO KNOWN AS SUNLINE) METHADONE?

VISUALINE II (ALSO KNOWN AS SUNLINE) METHADONE is a medical device that received FDA 510(k) clearance on 1998-09-04. The listed applicant is Sun Biomedical Laboratories, Inc.. The 510(k) number is K981314.

When did VISUALINE II (ALSO KNOWN AS SUNLINE) METHADONE receive FDA 510(k) clearance?

VISUALINE II (ALSO KNOWN AS SUNLINE) METHADONE received FDA 510(k) clearance on 1998-09-04, under 510(k) number K981314.

Who is the listed applicant for VISUALINE II (ALSO KNOWN AS SUNLINE) METHADONE?

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

What is the FDA product code for VISUALINE II (ALSO KNOWN AS SUNLINE) METHADONE?

The FDA product code for VISUALINE II (ALSO KNOWN AS SUNLINE) METHADONE is DJR.

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Other records listing Sun Biomedical Laboratories, Inc. as applicant

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.

K023856VISUALINE METHADONE DIPSTRIPTESTK023648VISUALINE CUP IV FOR DRUGS OF ABUSE TEST FOR QUALITATIVE DETERMINATION OF COCAINE, CANNABINOIDS, MORPHINE, METHAMPHETAMIK014089VISUALINE II (ALSO KNOWN AS SUNLINE) BARITURATESK020136VISUALINE BARBITURATES DIPSTRIP TESTK011499VISUALINE AMPHETAMINE DIPSTRIP ASSAYK010177VISUALINE II (ALSO KNOWN AS SUNLINE) AMPHETAMINE ASSAY

View all 17 devices →

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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