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FDA 510(k)

COBAS REAGENT FOR GLUCOSE RAPID

K-Number: K801297 · 1980-06-30

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

Device Summary

COBAS REAGENT FOR GLUCOSE RAPID 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 K801297. The device is classified under product code CFR. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COBAS REAGENT FOR GLUCOSE RAPID?

COBAS REAGENT FOR GLUCOSE RAPID 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 K801297.

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

COBAS REAGENT FOR GLUCOSE RAPID received FDA 510(k) clearance on 1980-06-30, under 510(k) number K801297.

Who is the listed applicant for COBAS REAGENT FOR GLUCOSE RAPID?

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 GLUCOSE RAPID?

The FDA product code for COBAS REAGENT FOR GLUCOSE RAPID is CFR.

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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 & COBASK801296COBAS REAGENT FOR CHOLESTEROLK801243COBAS REAGENTS FOR URIC ACIDK801242COBAS REAGENT FOR ALKALINE PHOSPHATASE

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Related Devices (Code: CFR)

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.

K253490Glucose HK Gen.3; ONLINE DAT Methadone II; cobas pro integrated solutionsRoche DiagnosticsK252357Glucose2Abbott IrelandK220134cobas pure integrated solutions, Glucose HK Gen.3, ISE indirect Na for Gen.2, ONLINE DAT Methadone II, Elecsys TSHRoche DiagnosticsK191899Glucose HK Gen.3, ISE indirect Na for Gen.2, Elecsys TSH, cobas pro integrated solutionsRoche DiagnosticsK170316ALINITY C GLUCOSE REAGENT KIT, ALINITY C SYSTEMAbbott LaboratoriesK153644ELITech Clinical Systems GLUCOSE HK SL, ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I and ELITROL IIElitechgroup

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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