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FDA 510(k)

AUTO-LYTE METHADONE DIA

K-Number: K944056 · 1994-12-29

ApplicantSolarcare Technologies Corp,Inc.
Decision Date1994-12-29
Product CodeDJR
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

AUTO-LYTE METHADONE DIA is the device name listed in this FDA 510(k) record. The listed applicant is Solarcare Technologies Corp,Inc.. It received FDA 510(k) clearance on 1994-12-29 under 510(k) number K944056. 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 AUTO-LYTE METHADONE DIA?

AUTO-LYTE METHADONE DIA is a medical device that received FDA 510(k) clearance on 1994-12-29. The listed applicant is Solarcare Technologies Corp,Inc.. The 510(k) number is K944056.

When did AUTO-LYTE METHADONE DIA receive FDA 510(k) clearance?

AUTO-LYTE METHADONE DIA received FDA 510(k) clearance on 1994-12-29, under 510(k) number K944056.

Who is the listed applicant for AUTO-LYTE METHADONE DIA?

The FDA 510(k) record lists Solarcare Technologies Corp,Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AUTO-LYTE METHADONE DIA?

The FDA product code for AUTO-LYTE METHADONE DIA is DJR.

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Other records listing Solarcare Technologies Corp,Inc. as applicant

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K954326STC DIAGNOSTICS AUTO-LYTE URINARY HEMOGLOBIN ASSAYK954156STC DIAGNOSTICS AUTO-LYTE URINARY LEUKOCYTE ESTERASE ASSAYK955905STC DIAGNOSTICS AUTO-LYTE URINARY PROTEIN ASSAYK954158STC DIAGNOSTICS AUTO-LYTE PH ASSAYK940048STC DIAGNOSTICS PCP MICRO-PLATE EIA MODIFICATIONK954073STC DIAGNOSTICS LSD MICRO-PLATE EIA

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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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