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FDA 510(k)

BI-LEVEL ACETAMINOPHEN-SALICYLATE CNRL

K-Number: K813349 · 1981-12-22

ApplicantStanbio Laboratory
Decision Date1981-12-22
Product CodeDIF
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

BI-LEVEL ACETAMINOPHEN-SALICYLATE CNRL is the device name listed in this FDA 510(k) record. The listed applicant is Stanbio Laboratory. It received FDA 510(k) clearance on 1981-12-22 under 510(k) number K813349. 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 BI-LEVEL ACETAMINOPHEN-SALICYLATE CNRL?

BI-LEVEL ACETAMINOPHEN-SALICYLATE CNRL is a medical device that received FDA 510(k) clearance on 1981-12-22. The listed applicant is Stanbio Laboratory. The 510(k) number is K813349.

When did BI-LEVEL ACETAMINOPHEN-SALICYLATE CNRL receive FDA 510(k) clearance?

BI-LEVEL ACETAMINOPHEN-SALICYLATE CNRL received FDA 510(k) clearance on 1981-12-22, under 510(k) number K813349.

Who is the listed applicant for BI-LEVEL ACETAMINOPHEN-SALICYLATE CNRL?

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

What is the FDA product code for BI-LEVEL ACETAMINOPHEN-SALICYLATE CNRL?

The FDA product code for BI-LEVEL ACETAMINOPHEN-SALICYLATE CNRL is DIF.

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Other records listing Stanbio Laboratory 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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