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FDA 510(k)

REAGENT FOR DETERM. INORGANIC/PHOSPHORUS

K-Number: K800690 · 1980-05-28

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

Device Summary

REAGENT FOR DETERM. INORGANIC/PHOSPHORUS 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 K800690. The device is classified under product code CEO. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REAGENT FOR DETERM. INORGANIC/PHOSPHORUS?

REAGENT FOR DETERM. INORGANIC/PHOSPHORUS 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 K800690.

When did REAGENT FOR DETERM. INORGANIC/PHOSPHORUS receive FDA 510(k) clearance?

REAGENT FOR DETERM. INORGANIC/PHOSPHORUS received FDA 510(k) clearance on 1980-05-28, under 510(k) number K800690.

Who is the listed applicant for REAGENT FOR DETERM. INORGANIC/PHOSPHORUS?

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. INORGANIC/PHOSPHORUS?

The FDA product code for REAGENT FOR DETERM. INORGANIC/PHOSPHORUS is CEO.

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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: CEO)

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.

K100263ELITECH CLINICAL SYSTEMS PHOSPHORUS, URIC ACID MONO SL AND UREA UV SL REAGENTSSeppim S.A.S.K072141S40 CLINICAL ANALYZER, S TEST IP, S TEST UAAlfa Wassermann Diagnostic Technologies, Inc.K041643SYNCHRON SYSTEMS PHOSPHORUS (PHS) REAGENTBeckman Coulter, Inc.K030015ATAC PAK PHOSPHORUS REAGENTElan DiagnosticsK022312PICCOLO PHOSPHORUS TEST SYSTEMAbaxis, Inc.K013095WIENER LAB.FOSFATEMIA UV, MODELS 1X100 ML CAT.N 1382321, 4X20 ML CAT.N 1009311Wiener Laboratories Saic

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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