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FDA 510(k)

URINE DRUG SCREENING CONTROL

K-Number: K992395 · 1999-08-26

ApplicantSeracare Technology
Decision Date1999-08-26
Product CodeDIF
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

URINE DRUG SCREENING CONTROL is the device name listed in this FDA 510(k) record. The listed applicant is Seracare Technology. It received FDA 510(k) clearance on 1999-08-26 under 510(k) number K992395. The device is classified under product code DIF. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the URINE DRUG SCREENING CONTROL?

URINE DRUG SCREENING CONTROL is a medical device that received FDA 510(k) clearance on 1999-08-26. The listed applicant is Seracare Technology. The 510(k) number is K992395.

When did URINE DRUG SCREENING CONTROL receive FDA 510(k) clearance?

URINE DRUG SCREENING CONTROL received FDA 510(k) clearance on 1999-08-26, under 510(k) number K992395.

Who is the listed applicant for URINE DRUG SCREENING CONTROL?

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

What is the FDA product code for URINE DRUG SCREENING CONTROL?

The FDA product code for URINE DRUG SCREENING CONTROL is DIF.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Seracare Technology 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.

K992939QUALITROL IMMUNOASSAY PLUS CONTROL, LEVELS 1,2 AND 3K993631QUALITROL TUMOR MARKER CONTROL, LEVELS 1 AND 2K993715QUALITROL CARDIAC MARKER CONTROL, LEVELS, 1,2 AND 3K992770QUALITROL IMMUNOLOGY CONTROL, LEVEL 1, 2 AND 3

Related Devices (Code: DIF)

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.

K153474Detectabuse Liquid Control Urine, Detectabuse Stat-Skreen Liquid Control Urine, Detectabuse Liquid Control Urine, AU/NZ, Detectabuse Liquid Control Urine, Immunoassay Series, Detectabuse Liquid Control Urine, GC/MS and Confirm seriesBiochemical Diagnostics, Inc.K132688SALIVABUSE LIQUID ORAL FLUID CONTROL, SALIVABUSE LIQUID ORAL FLUID CONTROL, AU/NZBiochemical Diagnostics, Inc.K132174MULTICHEM WBTTechno-Path Manufacturing , Ltd.K121122DETECTABUSE LIQUID CONTROL, DETECTABUSE STAT-SKREEN LIQUID CONTROLBiochemical Diagnostic, Inc.K121143LIQUICHEK WHOLE BLOOD IMMUNOSUPPRESSANT CONTROL TILEVEL (1,2 AND 3)Bio-Rad LaboratoriesK120504LIQUICHEK URINE TOXICOLOGY CONTROL, S10 & S10 MINIPAK, LIQUICHEK URINE TOXICOLOGY CONTROL, LEVEL S20 & LEVEL S20 MINIPAKBio-Rad Laboratories, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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