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FDA 510(k)

COBAS REAGENT FOR CHOLESTEROL

K-Number: K801296 · 1980-06-30

ApplicantRoche Analytical Instruments, Inc.
Decision Date1980-06-30
Product CodeCHH
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

COBAS REAGENT FOR CHOLESTEROL is the device name listed in this FDA 510(k) record. The listed applicant is Roche Analytical Instruments, Inc.. It received FDA 510(k) clearance on 1980-06-30 under 510(k) number K801296. The device is classified under product code CHH. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COBAS REAGENT FOR CHOLESTEROL?

COBAS REAGENT FOR CHOLESTEROL is a medical device that received FDA 510(k) clearance on 1980-06-30. The listed applicant is Roche Analytical Instruments, Inc.. The 510(k) number is K801296.

When did COBAS REAGENT FOR CHOLESTEROL receive FDA 510(k) clearance?

COBAS REAGENT FOR CHOLESTEROL received FDA 510(k) clearance on 1980-06-30, under 510(k) number K801296.

Who is the listed applicant for COBAS REAGENT FOR CHOLESTEROL?

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

What is the FDA product code for COBAS REAGENT FOR CHOLESTEROL?

The FDA product code for COBAS REAGENT FOR CHOLESTEROL is CHH.

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Other records listing Roche Analytical Instruments, 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.

K801299COBAS CK-NAC REAGENTK801295COBAS REAGENT FOR A-AMYLASEK801298COBAS REAGENT FOR TRIGLYCERIDES & COBASK801297COBAS REAGENT FOR GLUCOSE RAPIDK801243COBAS REAGENTS FOR URIC ACIDK801242COBAS REAGENT FOR ALKALINE PHOSPHATASE

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Related Devices (Code: CHH)

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.

K251091LipidsTruvian HealthK232404CHOLESTEROL; HDL-cholesterol ; LDL-cholesterol; TRIGLYCERIDESMedicon Hellas S.AK203597Cholesterol2Abbott Ireland Diagnostics DivisionK190490VITROS XT Chemistry Products TRIG-CHOL SlidesOrtho-Clinical Diagnostics, Inc.K181373Extended Lipid Panel AssayLaboratory Corporation of America HoldingsK180504Mission Lipid Panel Monitoring SystemACON Laboratories, 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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