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FDA 510(k)

ENZYMATIC CO2 DIAGNOSTIC CHEMICAL

K-Number: K841664 · 1984-06-08

ApplicantDiagnostic Chemicals, Ltd. (Usa)
Decision Date1984-06-08
Product CodeKHS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ENZYMATIC CO2 DIAGNOSTIC CHEMICAL is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostic Chemicals, Ltd. (Usa). It received FDA 510(k) clearance on 1984-06-08 under 510(k) number K841664. 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 ENZYMATIC CO2 DIAGNOSTIC CHEMICAL?

ENZYMATIC CO2 DIAGNOSTIC CHEMICAL is a medical device that received FDA 510(k) clearance on 1984-06-08. The listed applicant is Diagnostic Chemicals, Ltd. (Usa). The 510(k) number is K841664.

When did ENZYMATIC CO2 DIAGNOSTIC CHEMICAL receive FDA 510(k) clearance?

ENZYMATIC CO2 DIAGNOSTIC CHEMICAL received FDA 510(k) clearance on 1984-06-08, under 510(k) number K841664.

Who is the listed applicant for ENZYMATIC CO2 DIAGNOSTIC CHEMICAL?

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

What is the FDA product code for ENZYMATIC CO2 DIAGNOSTIC CHEMICAL?

The FDA product code for ENZYMATIC CO2 DIAGNOSTIC CHEMICAL is KHS.

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Other records listing Diagnostic Chemicals, Ltd. (Usa) 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.

K022538IMMUNODIP URINARY ALBUMIN SCREEN ASSAY, CATALOGUE NUMBER 790-25K974874BILIRUBIN-SL (TOTAL) ASSAYK932556AMMONIA ASSAY CAT. NO. 200-02K932766HDL-CHOLESTRAL(DEXTRAN SULFATE/MAGNESIUM)K932555DC-LINEATE CAT. NO. SE-091K925877DC-UIBC-CAL

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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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