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FDA 510(k)

SYNERMED ENZYMATIC CO2 REAGENT KIT

K-Number: K960793 · 1996-03-11

ApplicantSynermed, Inc.
Decision Date1996-03-11
Product CodeKHS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SYNERMED ENZYMATIC CO2 REAGENT KIT is the device name listed in this FDA 510(k) record. The listed applicant is Synermed, Inc.. It received FDA 510(k) clearance on 1996-03-11 under 510(k) number K960793. 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 SYNERMED ENZYMATIC CO2 REAGENT KIT?

SYNERMED ENZYMATIC CO2 REAGENT KIT is a medical device that received FDA 510(k) clearance on 1996-03-11. The listed applicant is Synermed, Inc.. The 510(k) number is K960793.

When did SYNERMED ENZYMATIC CO2 REAGENT KIT receive FDA 510(k) clearance?

SYNERMED ENZYMATIC CO2 REAGENT KIT received FDA 510(k) clearance on 1996-03-11, under 510(k) number K960793.

Who is the listed applicant for SYNERMED ENZYMATIC CO2 REAGENT KIT?

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

What is the FDA product code for SYNERMED ENZYMATIC CO2 REAGENT KIT?

The FDA product code for SYNERMED ENZYMATIC CO2 REAGENT KIT is KHS.

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Other records listing Synermed, 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.

K973109SYNERMED NEAR-INFRARED DIRECT BILIRUBIN REAGENT KITK972716SYNERMED TOTAL BILIRUBIN REAGENT KITK971491SYNERMED IR 200 CHEMISTRY ANALYZERK962479SYNERMED ISE REAGENTSK963939SYNERMED DIRECT BILIRUBIN REAGENT KITK953395SYNERMED CALCIUM REAGENT KIT

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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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