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FDA 510(k)

CARBON DIOXIDE - L3K ASSAY, CATALOGUE NUMBER 299-30/40/50

K-Number: K990754 · 1999-04-20

ApplicantDiagnostic Chemicals , Ltd.
Decision Date1999-04-20
Product CodeKHS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CARBON DIOXIDE - L3K ASSAY, CATALOGUE NUMBER 299-30/40/50 is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostic Chemicals , Ltd.. It received FDA 510(k) clearance on 1999-04-20 under 510(k) number K990754. 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 CARBON DIOXIDE - L3K ASSAY, CATALOGUE NUMBER 299-30/40/50?

CARBON DIOXIDE - L3K ASSAY, CATALOGUE NUMBER 299-30/40/50 is a medical device that received FDA 510(k) clearance on 1999-04-20. The listed applicant is Diagnostic Chemicals , Ltd.. The 510(k) number is K990754.

When did CARBON DIOXIDE - L3K ASSAY, CATALOGUE NUMBER 299-30/40/50 receive FDA 510(k) clearance?

CARBON DIOXIDE - L3K ASSAY, CATALOGUE NUMBER 299-30/40/50 received FDA 510(k) clearance on 1999-04-20, under 510(k) number K990754.

Who is the listed applicant for CARBON DIOXIDE - L3K ASSAY, CATALOGUE NUMBER 299-30/40/50?

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

What is the FDA product code for CARBON DIOXIDE - L3K ASSAY, CATALOGUE NUMBER 299-30/40/50?

The FDA product code for CARBON DIOXIDE - L3K ASSAY, CATALOGUE NUMBER 299-30/40/50 is KHS.

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Other records listing Diagnostic Chemicals , Ltd. 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.

K070383ENZYMATIC CREATININE ASSAY (265 SERIES)K063208MAGNESIUM ASSAY (XB), MODELS 125-12, 125-50 AND 125-S7K060139CRP-ADVANCE ASSAY, MODELS 250-20, 250-25K060140CRP-ADVANCE MULTI CALIBRATOR SET, MODEL SE-250K051757CALCIUM ADVANCE ASSAY, MODEL 145-20, 145-25, 145-20-91K051191DCL MICROALBUMIN ASSAY, MODEL 252-20

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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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