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FDA 510(k)

REAGENT FOR DETERM. CREATINE PHOSPHOKINA

K-Number: K800684 · 1980-05-28

ApplicantDiagnostic Solutions, Inc.
Decision Date1980-05-28
Product CodeJHY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

REAGENT FOR DETERM. CREATINE PHOSPHOKINA 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 1980-05-28 under 510(k) number K800684. The device is classified under product code JHY. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REAGENT FOR DETERM. CREATINE PHOSPHOKINA?

REAGENT FOR DETERM. CREATINE PHOSPHOKINA is a medical device that received FDA 510(k) clearance on 1980-05-28. The listed applicant is Diagnostic Solutions, Inc.. The 510(k) number is K800684.

When did REAGENT FOR DETERM. CREATINE PHOSPHOKINA receive FDA 510(k) clearance?

REAGENT FOR DETERM. CREATINE PHOSPHOKINA received FDA 510(k) clearance on 1980-05-28, under 510(k) number K800684.

Who is the listed applicant for REAGENT FOR DETERM. CREATINE PHOSPHOKINA?

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 REAGENT FOR DETERM. CREATINE PHOSPHOKINA?

The FDA product code for REAGENT FOR DETERM. CREATINE PHOSPHOKINA is JHY.

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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-K800681REAGENTS FOR DETERM. CO2 IN HUMAN SERUMK800691REAGENT FOR DETERM. LACTATE/DEHYDROGENAS

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Related Devices (Code: JHY)

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.

K132571ELECSYS CK-MB STAT IMMUNOASSAY, ELECSYS CK-MB IMMUNOASSAYRoche DiagnosticsK070835OLYMPUS CK-MB REAGENTOlympus Life & Material Science Europa GmbH (IrishK022757SPIFE CK KIT, MODEL 3332, 3333Helena LaboratoriesK022654MODIFICATION TO ELECSYS CK-MB STAT, ELECSYS CK-MBRoche Diagnostics Corp.K974421ELECSYS CK-MB STATBoehringer Mannheim Corp.K970343MMB METHODDade Chemistry Systems, 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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