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FDA 510(k)

ROCHE REAGENT FOR INORGANIC PHOSPHORUS

K-Number: K883962 · 1988-11-29

ApplicantRoche Diagnostic Systems, Inc.
Decision Date1988-11-29
Product CodeCEO
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ROCHE REAGENT FOR INORGANIC PHOSPHORUS is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostic Systems, Inc.. It received FDA 510(k) clearance on 1988-11-29 under 510(k) number K883962. 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 ROCHE REAGENT FOR INORGANIC PHOSPHORUS?

ROCHE REAGENT FOR INORGANIC PHOSPHORUS is a medical device that received FDA 510(k) clearance on 1988-11-29. The listed applicant is Roche Diagnostic Systems, Inc.. The 510(k) number is K883962.

When did ROCHE REAGENT FOR INORGANIC PHOSPHORUS receive FDA 510(k) clearance?

ROCHE REAGENT FOR INORGANIC PHOSPHORUS received FDA 510(k) clearance on 1988-11-29, under 510(k) number K883962.

Who is the listed applicant for ROCHE REAGENT FOR INORGANIC PHOSPHORUS?

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

What is the FDA product code for ROCHE REAGENT FOR INORGANIC PHOSPHORUS?

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

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Other records listing Roche Diagnostic Systems, 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.

K983698MODIFICATION TO ABUSCREEN ONLINE BARBITURATESK983702MODIFICATION TO ABUSCREEN ONLINE FOR BENZOIDIAZEPINESK983704MODIFICATION TO ABUSCREEN ONLINE FOR PHENCYCLIDINEK983556ABUSCREEN ONLINE BENZ 300 CALIBRATORSK983555ABUSCREEN ONLINE BENZ 200 CALIBRATORSK983700MODIFICATION TO ABUSCREEN ONLINE FOR PROPOXYPHENE

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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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