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FDA 510(k)

SYNCHRON SYUSTEMS DAT DRUG FREE URINE CONTROL

K-Number: K971534 · 1997-05-21

ApplicantBeckman
Decision Date1997-05-21
Product CodeDIF
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

SYNCHRON SYUSTEMS DAT DRUG FREE URINE CONTROL is the device name listed in this FDA 510(k) record. The listed applicant is Beckman. It received FDA 510(k) clearance on 1997-05-21 under 510(k) number K971534. 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 SYNCHRON SYUSTEMS DAT DRUG FREE URINE CONTROL?

SYNCHRON SYUSTEMS DAT DRUG FREE URINE CONTROL is a medical device that received FDA 510(k) clearance on 1997-05-21. The listed applicant is Beckman. The 510(k) number is K971534.

When did SYNCHRON SYUSTEMS DAT DRUG FREE URINE CONTROL receive FDA 510(k) clearance?

SYNCHRON SYUSTEMS DAT DRUG FREE URINE CONTROL received FDA 510(k) clearance on 1997-05-21, under 510(k) number K971534.

Who is the listed applicant for SYNCHRON SYUSTEMS DAT DRUG FREE URINE CONTROL?

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

What is the FDA product code for SYNCHRON SYUSTEMS DAT DRUG FREE URINE CONTROL?

The FDA product code for SYNCHRON SYUSTEMS DAT DRUG FREE URINE 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 Beckman 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.

K991707MODIFICATION TO ACCESS CEA REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 33200, 33205, 33209, 33206K935362P-AMYLASE CONTROLK904219SYNCHRON CX 7 CLINICAL ANALYZERK904220SYNCHRON CX4-CEK893583BECKMAN CHOLINESTERASE REAGENT KIT

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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