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FDA 510(k)

LYPHOCHEK THERAPEUTIC DRUG MONITORING CONTROL

K-Number: K880145 · 1988-06-20

ApplicantBio-Rad
Decision Date1988-06-20
Product CodeDIF
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

LYPHOCHEK THERAPEUTIC DRUG MONITORING CONTROL is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Rad. It received FDA 510(k) clearance on 1988-06-20 under 510(k) number K880145. 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 LYPHOCHEK THERAPEUTIC DRUG MONITORING CONTROL?

LYPHOCHEK THERAPEUTIC DRUG MONITORING CONTROL is a medical device that received FDA 510(k) clearance on 1988-06-20. The listed applicant is Bio-Rad. The 510(k) number is K880145.

When did LYPHOCHEK THERAPEUTIC DRUG MONITORING CONTROL receive FDA 510(k) clearance?

LYPHOCHEK THERAPEUTIC DRUG MONITORING CONTROL received FDA 510(k) clearance on 1988-06-20, under 510(k) number K880145.

Who is the listed applicant for LYPHOCHEK THERAPEUTIC DRUG MONITORING CONTROL?

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

What is the FDA product code for LYPHOCHEK THERAPEUTIC DRUG MONITORING CONTROL?

The FDA product code for LYPHOCHEK THERAPEUTIC DRUG MONITORING CONTROL is DIF.

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Other records listing Bio-Rad as applicant

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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

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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