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FDA 510(k)

REAGENTS FOR DETERM. CHOLESTEROL/SERUM

K-Number: K800682 · 1980-05-28

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

Device Summary

REAGENTS FOR DETERM. CHOLESTEROL/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 1980-05-28 under 510(k) number K800682. The device is classified under product code CGO. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REAGENTS FOR DETERM. CHOLESTEROL/SERUM?

REAGENTS FOR DETERM. CHOLESTEROL/SERUM 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 K800682.

When did REAGENTS FOR DETERM. CHOLESTEROL/SERUM receive FDA 510(k) clearance?

REAGENTS FOR DETERM. CHOLESTEROL/SERUM received FDA 510(k) clearance on 1980-05-28, under 510(k) number K800682.

Who is the listed applicant for REAGENTS FOR DETERM. CHOLESTEROL/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. CHOLESTEROL/SERUM?

The FDA product code for REAGENTS FOR DETERM. CHOLESTEROL/SERUM is CGO.

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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 SERUMK800677REAGENTS FOR DETERM. SERUM IRON IN HUMAN

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Related Devices (Code: CGO)

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.

K850938CHOLESTEROLDilab, Inc.K811747KING DIAGNOSTICS CHOLESTEROL TESTKing Diagnostics, Inc.K810090CHOLESTEROL REAGENTAnco Medical Reagents & Assoc.K781611CHOLESTEROL DET. IN SERUMFisher Scientific Co., LLCK780545SR-PLUS DIRECT CHOLESTEROL TESTStanbio LaboratoryK772043ALPHA/CHOLStandard Scientific, 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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