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FDA 510(k)

BIOTROL BICARBONATE (CO2) UV HP)

K-Number: K874941 · 1988-01-05

ApplicantBiotrol, USA, Inc.
Decision Date1988-01-05
Product CodeKHS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

BIOTROL BICARBONATE (CO2) UV HP) is the device name listed in this FDA 510(k) record. The listed applicant is Biotrol, USA, Inc.. It received FDA 510(k) clearance on 1988-01-05 under 510(k) number K874941. The device is classified under product code KHS. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOTROL BICARBONATE (CO2) UV HP)?

BIOTROL BICARBONATE (CO2) UV HP) is a medical device that received FDA 510(k) clearance on 1988-01-05. The listed applicant is Biotrol, USA, Inc.. The 510(k) number is K874941.

When did BIOTROL BICARBONATE (CO2) UV HP) receive FDA 510(k) clearance?

BIOTROL BICARBONATE (CO2) UV HP) received FDA 510(k) clearance on 1988-01-05, under 510(k) number K874941.

Who is the listed applicant for BIOTROL BICARBONATE (CO2) UV HP)?

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

What is the FDA product code for BIOTROL BICARBONATE (CO2) UV HP)?

The FDA product code for BIOTROL BICARBONATE (CO2) UV HP) is KHS.

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Other records listing Biotrol, USA, Inc. 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.

K934014VACUSOL PLUS DENTAL VACUUM LINE CLEANER/DISINFECTANTK931141BIOTROL AMYLASE CNPG3K921855BIOTROL BICARBONATE STANDARDSK921677BIOTROL MAGNESIUM (MAGON)K912795BIOTROL UIBC REAGENTK910721BIOTROL PROTEIN MULTILEVEL STANDARDS

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Related Devices (Code: KHS)

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.

K170200Carbon Dioxide Reagent SetTeco Diagnostics, Inc.K152085Liquid CO2-2 (LCO2-2)Randox Laboratories, Ltd.K131546AU BICARBONATE REAGENTBeckman Coulter Ireland, Inc.K123953ACE CARBON DIOXIDE REAGENT, ACE DIRECT BILIUBIN REAGENT, ACE TOTAL BILIRUBIN REAGENT, ACE MAGNESIUM REAGENTAlfa Wassermann Diagnostic Technologies, Inc.K120765VITROS CHEMISTRY PRODUCTS ECO2 SLIDESOrtho-Clinical Diagnostics, Inc.K113435ACE CARBON DIOXIDE(CO2-LC) REAGENT, ACE DIRECT BILIRUBIN REAGENT, ACE TOTAL BILIRUBIN REAGENT, ACE MAGNESIUM REAGENTAlfa Wassermann

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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