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FDA 510(k)

Q-PAK URINE TOXICOLOGY CONTROL, UNASSAY.

K-Number: K821973 · 1982-07-20

ApplicantTravenol Laboratories, S.A.
Decision Date1982-07-20
Product CodeDIF
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

Q-PAK URINE TOXICOLOGY CONTROL, UNASSAY. is the device name listed in this FDA 510(k) record. The listed applicant is Travenol Laboratories, S.A.. It received FDA 510(k) clearance on 1982-07-20 under 510(k) number K821973. 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 Q-PAK URINE TOXICOLOGY CONTROL, UNASSAY.?

Q-PAK URINE TOXICOLOGY CONTROL, UNASSAY. is a medical device that received FDA 510(k) clearance on 1982-07-20. The listed applicant is Travenol Laboratories, S.A.. The 510(k) number is K821973.

When did Q-PAK URINE TOXICOLOGY CONTROL, UNASSAY. receive FDA 510(k) clearance?

Q-PAK URINE TOXICOLOGY CONTROL, UNASSAY. received FDA 510(k) clearance on 1982-07-20, under 510(k) number K821973.

Who is the listed applicant for Q-PAK URINE TOXICOLOGY CONTROL, UNASSAY.?

The FDA 510(k) record lists Travenol Laboratories, S.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Q-PAK URINE TOXICOLOGY CONTROL, UNASSAY.?

The FDA product code for Q-PAK URINE TOXICOLOGY CONTROL, UNASSAY. is DIF.

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Other records listing Travenol Laboratories, S.A. 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.

K874181BAXTER BEDSIDE SYSTEMK873894CONTINU-FLO SOLUTION W/CHECK VALVE 2 Y-INJECT SITEK873873RESUBMITTED MICRON TRANSFUSION FILTERK873984AUTOMATIC PERITONEAL DIALYSIS CYCLER SET (5C4437)K872364HEMODIALYSIS (SPS), MODEL 550, CODE 5M1309K872652UPGRADED AUTO PERITONEAL DIALYSIS CYCLER SYSTEM

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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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