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FDA 510(k)

REAGENTS FOR DETERM. CO2 IN HUMAN SERUM

K-Number: K800681 · 1980-05-30

ApplicantDiagnostic Solutions, Inc.
Decision Date1980-05-30
Product CodeKMS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

REAGENTS FOR DETERM. CO2 IN HUMAN SERUM is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostic Solutions, Inc.. It received FDA 510(k) clearance on 1980-05-30 under 510(k) number K800681. The device is classified under product code KMS. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REAGENTS FOR DETERM. CO2 IN HUMAN SERUM?

REAGENTS FOR DETERM. CO2 IN HUMAN SERUM is a medical device that received FDA 510(k) clearance on 1980-05-30. The listed applicant is Diagnostic Solutions, Inc.. The 510(k) number is K800681.

When did REAGENTS FOR DETERM. CO2 IN HUMAN SERUM receive FDA 510(k) clearance?

REAGENTS FOR DETERM. CO2 IN HUMAN SERUM received FDA 510(k) clearance on 1980-05-30, under 510(k) number K800681.

Who is the listed applicant for REAGENTS FOR DETERM. CO2 IN HUMAN SERUM?

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

What is the FDA product code for REAGENTS FOR DETERM. CO2 IN HUMAN SERUM?

The FDA product code for REAGENTS FOR DETERM. CO2 IN HUMAN SERUM is KMS.

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Other records listing Diagnostic Solutions, 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.

K934892RELIEF PLUS ONE REAGENT STRIP MODIFICATIONK924398UNI-CHECK REAGENT STRIPK921825QUICK-CHECK II REAGENT STRIPK800689REAGENT FOR DETERM. GLUTAMIC-PYRUVIC-K800677REAGENTS FOR DETERM. SERUM IRON IN HUMANK800682REAGENTS FOR DETERM. CHOLESTEROL/SERUM

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Related Devices (Code: KMS)

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.

K872886CARBON DIOXIDECatachem, Inc.K870025AMRESCO FLOW PAC CARBON DIOXIDE (CO2) REAGENTSAmerican Research Products Co.K802162CO2 COLOR REAGENT & CO2 SAMPLE DILUENTPanmed, Inc.K780506CARBON DIOXIDE REAGENTSGamma Enterprises, 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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